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Open, Classified

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

FDA Recall Z-1317-2024 · Posted 2024-03-19

Recalling FirmMedtronic Inc.
Recall StatusOpen, Classified
Product CodeQAN
Date Initiated2024-02-16
Product Quantity65 units

Reason for Recall

There is a potential for sterile package breach.

Firm 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.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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