The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0080-2021·Announced 2020-10-14

Bard Conquest PTA Balloon Catheter Recalled for Incorrect Balloon Size

Bard Peripheral Vascular Inc is recalling 281 units of the Conquest PTA Balloon Dilation Catheter because some units contain a 5mm balloon instead of the labeled 6mm size.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the potential consequence is 'inconsequential prolongation' and no injuries are reported, fitting the criteria for a moderate risk of harm where injury has not yet been reported or is minor.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 281 units of the Bard Conquest PTA Balloon Dilation Catheter, 6mm x 40mm, 75 cm (Cat. No. CQ7564, Lot No. REDU2646). The recall is due to a packaging error where the catheter was packaged with a 5mm x 40mm balloon instead of the 6mm x 40mm balloon stated on the labeling.

The affected product is intended for 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. The distribution pattern includes worldwide distribution and US nationwide distribution in specific states including GA, AZ, MD, CA, VA, AR, TX, SD, NC, MO, WI, CO, FL, PA, and the country of Taiwan.

The FDA classifies this as a Class II recall. The source text notes that use of a balloon with a smaller diameter than expected could result in inconsequential prolongation of an existing procedure. No injuries or illnesses have been reported in the source text.

The recalled product

Product
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…
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Vascular Catheter
Hazard
Affected units
281

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot No. REDU2646 Expiration Date: 06/30/2022

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

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