Device recall: POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

Class II FDA enforcement event 79841. Recall start date: 8 Feb 2018. Status in the FDA record: Completed.

Reason for recall, in the words of FDA

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

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 8 Feb 2018. The firm address in the FDA record is in Tempe, AZ. FDA put the recall in Class II. FDA event 79841 has 14 product records. The first FDA enforcement report date is 16 May 2018. The record gives the status Completed.

FDA enforcement report The 14 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.

Nationwide

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

14 product records in the event.

FDA event 79841: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1760-2018	POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362	359 units	Class II	Completed	16 May 2018
Z-1761-2018	POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362	2395 units	Class II	Completed	16 May 2018
Z-1762-2018	POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300	1551 units	Class II	Completed	16 May 2018
Z-1763-2018	POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301	216 units	Class II	Completed	16 May 2018
Z-1764-2018	POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300	2835 units	Class II	Completed	16 May 2018
Z-1765-2018	POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301	383 units	Class II	Completed	16 May 2018
Z-1766-2018	POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362	876 units	Class II	Completed	16 May 2018
Z-1767-2018	POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362	4044 units	Class II	Completed	16 May 2018
Z-1768-2018	POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300	3196 units	Class II	Completed	16 May 2018
Z-1769-2018	POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301	835 units	Class II	Completed	16 May 2018
Z-1770-2018	POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300	1411 units	Class II	Completed	16 May 2018
Z-1771-2018	POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301	181 units	Class II	Completed	16 May 2018
Z-1772-2018	POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004	15 units	Class II	Completed	16 May 2018
Z-1773-2018	POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005	10 units	Class II	Completed	16 May 2018

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 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 14Median 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-1760-2018The 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 79841. https://recallregister.com/fda/ii/79841/. 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: Nationwide
What quantity of product is in FDA event 79841?: The event has 14 product records. The first record gives this quantity: 359 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.