FDA Medical devices recall ·
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN:… recall
- Recall number
- Z-1024-2025
- Date
- (initiated December 20, 2024)
- Company / brand
- Boston Scientific Corporation
100 Boston Scientific Way, Marlborough, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 495 units US; 2 units(OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Why was it recalled?
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN: 08714729904588 Lot Numbers: 32891042, 32900457, 32908438, 33215358, 33215359, 33216060, 33216062, 33219660, 33219662, 33219663, 33315967, 33315970, 33324398, 33500190, 33520871, 33520872, 33537659, 33538481, 33538484, 33559005, 33813654, 33813655, 33871244, 33948086, 33996038, 33996039, 34004999, 34116469, 34116470, 34251352, 34251353, 34261614, 34261615, 34261616, 34263376, 34263377, 34277689, 34277690, 34297653, 34297657, 34512952, 34526862
Distribution
Nationwide including Puerto Rico Foreign: To be provided
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1024-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.