Recalls / —

—#206502

Product

Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

FDA product code

QAN — Stent, Iliac Vein

Device class

Class 3

Medical specialty

Unknown

Affected lot / code info

a) AB9U14080090, UDI/DI 00643169796294, Batch Number B456626; b) AB9U18100090, UDI/DI 00643169796409, Batch Number B456811; c) AB9G14100090, IUDI/DI 00763000547325, Batch Number B460542

Why it was recalled

There is a potential for sterile package breach.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Medtronic Inc.

Address

4600 Nathan Ln N, Plymouth, Minnesota 55442-2890

Distribution

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom.

Timeline

Recall initiated

2024-02-16

Posted by FDA

2024-03-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #206502. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.