Recall Z-0774-2021 ยท PCU Pancreatic Stent, Covered, Metallic, Removable
Boston Scientific Corporation
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - 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.
| Date | Dec 1, 2020 |
| Status | Terminated |
| 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 |
| Root cause | Process control |
| Action | Boston Scientific issued customer notification letters to consignees via Federal Express Priority Overnight mail on December 1, 2020. The letter states reason for recall, health risk and action to take: Cease further distribution or use of any remaining product affected by this removal immediately. Verify by product lot/batch number in the product table whether any product within your inventory is affected. If so, indicate on your Reply Verification Tracking Form the quantity of units from each lot/batch that you will be returning. If you identify any product from the affected lots/batches w |
| Quantity | 32 units |
| Distribution | US Nationwide distribution - Foreign: TBD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System Boston Scientific Corporation, Mar 25, 2019 |