Bard Peripheral Vascular Inc: FDA recalls

FDA enforcement reports name Bard Peripheral Vascular Inc as the recalling firm in 56 events. The events have 139 product records. The recalls started from 2013 to 2025. All the events are device recalls.

See the 56 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

56 events, newest first.

FDA enforcement events of Bard Peripheral Vascular Inc
Initiated	Product (first record)	Type	Class	Records	Status
12 Dec 2025	Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060	Device	Class II	1	Ongoing
6 Nov 2025	Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,	Device	Class II	1	Ongoing
21 Aug 2025	Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures…	Device	Class II	1	Ongoing
5 Feb 2025	Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239	Device	Class I	1	Ongoing
30 Sep 2024	Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213	Device	Class II	1	Ongoing
4 Sep 2024	The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop…	Device	Class II	1	Ongoing
2 Aug 2024	BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.	Device	Class II	1	Ongoing
10 Jul 2024	Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.	Device	Class II	1	Ongoing
14 Nov 2023	BD Recanalization System, REF: BDRECANSYSTEM	Device	Class II	1	Ongoing
8 Nov 2023	Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Kit 18G x 20CM; 1825MSK/ Mission Kit 18G…	Device	Class II	1	Ongoing
10 Aug 2023	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016	Device	Class II	1	Ongoing
11 Apr 2023	Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM	Device	Class II	1	Ongoing
28 Feb 2023	Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK	Device	Class II	1	Ongoing
4 Jan 2023	Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV…	Device	Class II	1	Ongoing
22 Dec 2022	The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.	Device	Class II	1	Ongoing
22 Apr 2022	REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,	Device	Class II	1	Ongoing
20 Jan 2022	Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer	Device	Class II	11	Ongoing
24 Aug 2021	Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow…	Device	Class II	2	Terminated
27 Jul 2021	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796	Device	Class II	1	Ongoing
23 Jun 2021	TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm; TJC4011 Jamshidi" Bone Marrow…	Device	Class II	3	Ongoing
25 Mar 2021	PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood…	Device	Class II	3	Terminated
14 Jan 2021	BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents	Device	Class II	1	Terminated
14 Dec 2020	VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200mm OUS VENEL16080 Venovo 10F 16/80/1200mm OUS VENEL16100 Venovo 10F 16/100/1200mm OUS VENEL16120 Venovo 10F 16/120/1200mm OUS VENEL16140 Venovo 10F 16/140/1200mm OUS VENEL16160…	Device	Class II	3	Ongoing
1 Oct 2020	Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.	Device	Class II	1	Terminated
17 Mar 2020	Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.	Device	Class II	1	Terminated
15 Jan 2020	BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the…	Device	Class II	1	Ongoing
3 Jan 2020	Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.	Device	Class II	4	Terminated
25 Oct 2019	BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.	Device	Class II	1	Terminated
1 Oct 2019	1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single- Lumen Venous Catheter, REF: 1709601, Air Guard, Without Suture Plugs, (01)00801741026737; 3.…	Device	Class II	10	Terminated
14 Aug 2019	Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444	Device	Class II	1	Terminated
14 Jun 2019	EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F	Device	Class II	2	Terminated
31 May 2019	EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799	Device	Class II	28	Terminated
2 May 2019	EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.	Device	Class II	6	Terminated
12 Apr 2019	BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF)…	Device	Class II	1	Terminated
18 Feb 2019	LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code Stent Diameter Stent length Catheter Length…	Device	Class II	1	Terminated
14 Feb 2019	PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter	Device	Class II	1	Ongoing
25 Jun 2018	POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and…	Device	Class II	1	Completed
16 Apr 2018	BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.	Device	Class II	2	Terminated
8 Feb 2018	POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362	Device	Class II	14	Completed
22 Sep 2017	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.	Device	Class II	1	Terminated
28 Mar 2017	MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the…	Device	Class II	1	Terminated
2 Dec 2016	Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures requiring percutaneous introduction of…	Device	Class I	3	Terminated
6 Jul 2016	Bard TruGuide Disposable Coaxial Biopsy Needle – Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.	Device	Class II	1	Terminated
9 Feb 2016	Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.	Device	Class II	2	Terminated
4 Feb 2016	Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.	Device	Class II	1	Terminated
5 Jan 2016	Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.	Device	Class II	2	Terminated
19 Oct 2015	FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is…	Device	Class II	1	Terminated
9 Apr 2015	BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color-coded according to the various gauge sizes…	Device	Class II	1	Terminated
23 Mar 2015	Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.	Device	Class II	1	Terminated
17 Mar 2015	Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core…	Device	Class II	1	Terminated
13 Mar 2015	Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.	Device	Class II	1	Terminated
26 Aug 2014	Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies.	Device	Class II	1	Terminated
30 Sep 2013	Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in…	Device	Class I	1	Terminated
28 May 2013	BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic…	Device	Class II	1	Terminated
16 Apr 2013	BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.	Device	Class II	1	Terminated
23 Jan 2013	BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0…	Device	Class II	4	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Bard Peripheral Vascular Inc: events for each product type
Type		Events
Device		56

Bard Peripheral Vascular Inc: events in each class
Class		Events
Class II		53
Class I		3

Share of the events of the firm in Class I: 5%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 22

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Bard Peripheral Vascular Inc, by the year that the recall started. The largest year is 2019, with 9 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Bard Peripheral Vascular Inc: FDA recalls. https://recallregister.com/firm/bard-peripheral-vascular-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: AZ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Bard Peripheral Vascular Inc have?: Class II: 53 events. Class I: 3 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Bard Peripheral Vascular Inc?: FDA event 98222, which the firm started on 12 Dec 2025. The first product in the record is: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
How many FDA recalls of Bard Peripheral Vascular Inc have the status Ongoing?: 22 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.