FDA Device recall Z-0080-2021
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat
- FDA Device
- Class II
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II recall of Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat by Bard Peripheral Vascular, citing 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 ha….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0080-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-01 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot No. REDU2646 Expiration Date: 06/30/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0080-2021%22
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