—#184810

Product

AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - 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.

FDA product code: PCU — Pancreatic Stent, Covered, Metallic, Removable
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K181905
Affected lot / code info: Lot Number: 26134666 Exp. Date: 10/6/2022 GTIN:08714729904588

Why it was 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

Root cause (FDA determination)

Process control

Action the firm took

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 within your inventory, please segregate the product immediately and return it to BSC in accordance with the enclosed instructions. If you are a distributor, please note that the depth of this removal is to the end user level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital or facility within your network, please ensure that this notification is forwarded to them. Your local Sales Representative can answer any questions that you may have regarding this notification.

Recalling firm

Firm: Boston Scientific Corporation
Address: 300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291

Distribution

Distribution pattern: US Nationwide distribution - Foreign: TBD.

Timeline

Recall initiated: 2020-12-01
Terminated: 2023-07-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184810. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.