Hot AXIOS Stent and Electrocautery - Enhanced Delivery recall
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation…
Why was Hot AXIOS Stent and Electrocautery - Enhanced Delivery recalled?
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 26130517 Exp. Date Range: 10/5/2022 GTIN: 08714729904564
- Product
- Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 8 units
- Distribution
- US Nationwide distribution - Foreign: TBD.
- Recall date
- January 13, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)