Recall Z-1317-2024 ยท QAN Stent, Iliac Vein
Medtronic Inc.
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
| Date | Mar 19, 2024 (initiated Feb 16, 2024) |
| Status | Open, Classified |
| Reason | There is a potential for sterile package breach. |
| Root cause | Process control |
| Action | Medtronic issued and URGENT: MEDICAL DEVICE RECALL notice to it consignees on 02/16/2024 via FedEx. The notice explained the issue and requested the consignee immediately remove, and quarantine all impacted devices pending a follow-up communication providing additional information pertaining to product retrieval for this issue within 2-3 weeks. |
| Quantity | 65 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.