Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
FDA device recall Z-1317-2024 · posted 2024-03-19 · Open, Classified
Recall details
- Recalling firm
- Medtronic Inc.
- Reason for recall
- There is a potential for sterile package breach.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- QAN
- Quantity affected
- 65 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom.
- Date initiated
- 2024-02-16
- Date posted
- 2024-03-19
- Location
- Plymouth, MN
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