Recall Z-0080-2021 ยท DQY Catheter, Percutaneous
Bard Peripheral Vascular Inc
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.
| Date | Oct 1, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | On October 1, 2020, the firm mailed consignees a "Urgent Medical Device Recall Notification" via Fed EX that informed consignees about the recall. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 2. Immediately review your inventory for the specific Catalog and lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 3. Complete the at |
| Quantity | 281 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083657 | CONQUEST PTA BALLOON DILATATION CATHETER C.R. Bard, Inc., Dec 24, 2008 |