Bard Conquest PTA Balloon dilation Catheter — Class II medical device recall Z-0080-2021
Terminated recall by Bard Peripheral Vascular Inc, reported 2020-10-14, distributed nationwide. Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40m
| Recall number | Z-0080-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2020-10-01 |
| Classified | 2020-10-08 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2022-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | TW |
| Quantity | 281 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00801741062902 |
| Lot numbers | REDU2646 |
| Model numbers | CQ7564 |
| Expiration dates | 2022-06-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0080-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.