Recall Z-1317-2024— Medtronic Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Inc., initiated 2024-02-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090. Reason: There is a potential for sterile package breach..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-16
- Firm location
- Plymouth, MN, United States
Product description
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Reason for recall
There is a potential for sterile package breach.
Data sourced from openFDA. This site is unofficial and independent of the FDA.