FDA Medical Device Recalls (openFDA)
Medtronic Inc.: Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
- Recall number
- Z-1317-2024
- Recalling firm
- Medtronic Inc.
- Product
- Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
- Status
- Open, Classified
- Initiated
- 2024-02-16
- Posted
- 2024-03-19
- Terminated
- not on file
- Reason
- There is a potential for sterile package breach.
- Root cause
- Process control
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- a) AB9U14080090, UDI/DI 00643169796294, Batch Number B456626; b) AB9U18100090, UDI/DI 00643169796409, Batch Number B456811; c) AB9G14100090, IUDI/DI 00763000547325, Batch Number B460542
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QAN
- Firm FEI
- 2183870
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28