Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

There have been reports of stent migration.

Recommended Action

Per FDA guidance

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's normal follow-up procedures, and the enclosed Customer Confirmation Form be completed and emailed to the firm. The updated electronic IFU will be available before the end of the calendar year. In Outside the United States (OUS) geographies, communication of the Medical Device Correction letter began 11/24/2021 via regionally approved methods. Consignees will be notified of the upcoming IFU change, as well as provided the content of the IFU change. Consignees will be asked to complete and return a confirmation certificate confirming they have received the notification. The IFU for OUS consignees will be available in the summer of 2022.