Boston Scientific Corporation Recall 86909
Description: 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.
Boston Scientific Corporation Recall 86909 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0778-2021 |
| Event ID | 86909 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution - Foreign: TBD. |
| Quantity | 78 units |
| Recall Reason | 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 |
| Device Classification | 20210113 |
| Device Code Info | Lot Number: 26167277, 26171099, 26152171, 26171383, 26171380, 26152172 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951100 |
| Center Classification Date | 20210106 |
| Recall Initiation Date | 20201201 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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