Recall Z-1532-2021 ยท QAN Stent, Iliac Vein
Medtronic Inc.
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
| Date | Mar 16, 2021 |
| Status | Terminated |
| Reason | Incorrect size printed on the device; packaging is labeled correctly. |
| Root cause | Process control |
| Action | Beginning 16-Mar-2021, Medtronic initiated verbal communications to consignees in possession of affected units. Consignees were advised to quarantine all affected units within their possession, pending retrieval. A written Medical Device Correction letter was mailed on 03/30/2021 via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification. Consignees are also asked to return all unused, affected product within their possession. |
| Quantity | 23 devices |
| Distribution | US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.