Recall Z-0464-2022 ยท QAN Stent, Iliac Vein
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
| Date | Nov 19, 2021 |
| Status | Terminated |
| Reason | There have been reports of stent migration. |
| Root cause | Other |
| Action | The firm issued letters dated November 2021 on 11/19/2021 via 2-day UPS delivery to the U.S. consignees. The letter informs the consignee of the upcoming updates to the Instruction for Use (IFU) for the Abre venous self-expanding stent system and explains the updates will provide new information to help mitigate the risk of possible stent migration. The Customer Instructions in the letter requests the enclosed upcoming updates to the IFU be reviewed, the letter is shared with all those who need to be aware within their organization, patients should continue to be monitored per their practice |
| Quantity | 21,653 devices |
| Distribution | Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.