Recalls / —

—#190621

Product

Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

FDA product code

QAN — Stent, Iliac Vein

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P200026

Affected lot / code info

The IFU for all model numbers and serial numbers.

Why it was recalled

There have been reports of stent migration.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Address

8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern

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, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kenya, Lithuania, Malaysia, Republic of Moldova, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Viet Nam,

Timeline

Recall initiated

2021-11-19

Terminated

2024-08-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #190621. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.