Medtronic Inc. Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Brand
Medtronic Inc.
Lot Codes / Batch Numbers
a) AB9U14080090, UDI/DI 00643169796294, Batch Number B456626, b) AB9U18100090, UDI/DI 00643169796409, Batch Number B456811, c) AB9G14100090, IUDI/DI 00763000547325, Batch Number B460542
Products Sold
a) AB9U14080090, UDI/DI 00643169796294, Batch Number B456626; b) AB9U18100090, UDI/DI 00643169796409, Batch Number B456811; c) AB9G14100090, IUDI/DI 00763000547325, Batch Number B460542
Medtronic Inc. is recalling Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) A due to There is a potential for sterile package breach.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for sterile package breach.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026