FDAFDA · Food and drugs·Recall number Z-0778-2021
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Published January 13, 2021 · Recall initiated: December 1, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- US Nationwide distribution - Foreign: TBD.
- Lot
- Lot Number: 26167277, 26171099, 26152171, 26171383, 26171380, 26152172 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951100
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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