Device recall: EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit…

Class II FDA enforcement event 83337. Recall start date: 31 May 2019. Status in the FDA record: Terminated. Termination date: 17 May 2022.

Reason for recall, in the words of FDA

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Bard Peripheral Vascular Inc started this device recall on 31 May 2019. The firm address in the FDA record is in Tempe, AZ. FDA put the recall in Class II. FDA event 83337 has 28 product records. The first FDA enforcement report date is 4 Sep 2019. The record gives the status Terminated, with the termination date 17 May 2022.

FDA enforcement report The 28 product records

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.

Distribution

In the words of FDA.

US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT,…

Recalling firm

Bard Peripheral Vascular Inc, Tempe, AZ.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

28 product records in the event.

FDA event 83337: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2368-2019	EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799	34 units	Class II	Terminated	4 Sep 2019
Z-2369-2019	EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805	135 units	Class II	Terminated	4 Sep 2019
Z-2370-2019	EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812	40 units	Class II	Terminated	4 Sep 2019
Z-2371-2019	EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690	1356 units	Class II	Terminated	4 Sep 2019
Z-2372-2019	EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 00801741013706	1731 units	Class II	Terminated	4 Sep 2019
Z-2373-2019	EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013713	161 units	Class II	Terminated	4 Sep 2019
Z-2374-2019	EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801741013720	13 units	Class II	Terminated	4 Sep 2019
Z-2375-2019	EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013775	39 units	Class II	Terminated	4 Sep 2019
Z-2376-2019	EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904	0 units	Class II	Terminated	4 Sep 2019
Z-2377-2019	EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836	455 units	Class II	Terminated	4 Sep 2019
Z-2378-2019	EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight, 23cm length, BARD, UDI: 00801741013843	1,114 units	Class II	Terminated	4 Sep 2019
Z-2379-2019	EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913270, 16F, Straight, 27cm length, BARD, UDI: 00801741013850	309 units	Class II	Terminated	4 Sep 2019
Z-2380-2019	EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801741013874	46 units	Class II	Terminated	4 Sep 2019
Z-2381-2019	EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867	2 units	Class II	Terminated	4 Sep 2019
Z-2382-2019	EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881	100 units	Class II	Terminated	4 Sep 2019
Z-2383-2019	GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393190, 14.5F, Straight, 19cm length, BARD, UDI: 00801741012174	7,070 units	Class II	Terminated	4 Sep 2019
Z-2384-2019	GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 00801741012181	10,507 units	Class II	Terminated	4 Sep 2019
Z-2385-2019	GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393270, 14.5F, Straight, 27cm length, BARD, UDI: 00801741012198	2,298 units	Class II	Terminated	4 Sep 2019
Z-2386-2019	GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight, 42cm length, BARD, UDI: 00801741012228	713 units	Class II	Terminated	4 Sep 2019
Z-2387-2019	GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012242	240 units	Class II	Terminated	4 Sep 2019
Z-2388-2019	GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012259	570 units	Class II	Terminated	4 Sep 2019
Z-2389-2019	GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD, UDI: 00801741012266	104 units	Class II	Terminated	4 Sep 2019
Z-2390-2019	GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801741012297	1,679 units	Class II	Terminated	4 Sep 2019
Z-2391-2019	GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801741012303	899 units	Class II	Terminated	4 Sep 2019
Z-2392-2019	GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight, 27cm length, BARD, UDI: 00801741012310	887 units	Class II	Terminated	4 Sep 2019
Z-2393-2019	GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight, 31cm length, BARD, UDI: 00801741012327	91 units	Class II	Terminated	4 Sep 2019
Z-2394-2019	GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397350, 14.5F, straight, 35cm length, BARD, UDI: 00801741012334	39 units	Class II	Terminated	4 Sep 2019
Z-2395-2019	GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801741012358	140 units	Class II	Terminated	4 Sep 2019

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 28Median of the firm: 1
Events of the firm on the register: 56

Other events of the firm

Other FDA enforcement events of Bard Peripheral Vascular Inc
Initiated	Product (first record)	Type	Class	Records
12 Dec 2025	Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060	Device	Class II	1
6 Nov 2025	Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,	Device	Class II	1
21 Aug 2025	Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Vencl	Device	Class II	1
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: 80	Device	Class I	1
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	Device	Class II	1
4 Sep 2024	The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedur	Device	Class II	1
2 Aug 2024	BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy Syste	Device	Class II	1
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	Device	Class II	1
14 Nov 2023	BD Recanalization System, REF: BDRECANSYSTEM	Device	Class II	1
8 Nov 2023	Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G	Device	Class II	1

Bard Peripheral Vascular Inc: all 56 events

Official channels

FDA enforcement report Z-2368-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 83337. https://recallregister.com/fda/ii/83337/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT,…
What quantity of product is in FDA event 83337?: The event has 28 product records. The first record gives this quantity: 34 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.