# FDA recall Z-0080-2021

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2020-10-01.

## 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 arteriovenous dialysis fistulae.

## Reason for recall

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.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of GA, AZ, MD, CA, VA, AR, TX, SD, NC, MO, WI, CO, FL, PA and the country of Taiwan.

## Key facts

- **Recall number:** Z-0080-2021
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-01
- **Report date:** 2020-10-14
- **Termination date:** 2022-05-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0080-2021

## Citation

> AI Analytics. FDA recall Z-0080-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0080-2021. Source: US FDA. Licensed CC0.

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