Medtronic Abre Venous Stent System Recalled for Sterile Package Breach
Medtronic is recalling Abre Venous Self-expanding Stent Systems due to a potential for sterile package breach. The recalled systems consist of three product numbers totaling 65 units distributed worldwide. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a potential sterile package breach. The hazard is explicitly described as potential rather than confirmed, and no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injuries score 3 (High).
Plain-English summary
Medtronic Inc. is recalling the Abre Venous Self-expanding Stent System due to a potential for sterile package breach. Three product numbers are affected: AB9U14080090 (Batch B456626), AB9U18100090 (Batch B456811), and AB9G14100090 (Batch B460542), with a total of 65 units identified.
The affected products have been distributed worldwide, including throughout the United States and internationally to Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, and the United Kingdom. Patients who have received or may receive one of these stent systems should consult their healthcare provider.
No adverse events or patient injuries have been reported in connection with this recall. If you have received one of the affected stent systems, contact your healthcare provider or Medtronic for guidance on next steps.
The recalled product
- Product
- Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Venous Stent
- Hazard
- sterile-package-breach
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- a) AB9U14080090
- UDI/DI 00643169796294
- Batch Number B456626
- b) AB9U18100090
- UDI/DI 00643169796409
- Batch Number B456811
- c) AB9G14100090
- IUDI/DI 00763000547325
- Batch Number B460542
Distribution
Distributed nationwide across the United States.
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