Reported Oct 14, 2020 · Terminated
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product…
Bard Peripheral Vascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St Bldg 1 · Tempe, AZ · 85281-2438
Is this the product you have?
Bard Conquest PTA Balloon dilation Catheter6mm x 40mm75 cmCat. No. CQ7564
- UDI(01) 00801741062902 -
- Product Usageuse 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
- Lot codes and dates
- Lot No
- REDU2646 Expiration Date06/30/2022
- Amount recalled
- 281 units
Where it was sold
Why it was recalled
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Bard Peripheral Vascular Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.