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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOS Stent and Electrocautery

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  Class 2 Device Recall AXIOS Stent and Electrocautery see related information
Date Initiated by Firm December 01, 2020
Create Date January 06, 2021
Recall Status1 Terminated 3 on July 14, 2023
Recall Number Z-0775-2021
Recall Event ID 86909
510(K)Number K181905  
Product Classification Pancreatic stent, covered, metallic, removable - Product Code PCU
Product AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - 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.
Code Information Lot Number: 26167271, 26152176,26167274 Exp. Date Range: 10/8/2021 10/12/2021  GTIN: 08714729951179
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
763-494-1556
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 38 units
Distribution US Nationwide distribution - Foreign: TBD.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PCU and Original Applicant = Boston Scientific Corporation
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