Date Initiated by Firm | December 01, 2020 |
Create Date | January 06, 2021 |
Recall Status1 |
Terminated 3 on July 14, 2023 |
Recall Number | Z-0773-2021 |
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 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. |
Code Information |
Lot Number: 26134666 Exp. Date: 10/6/2022 GTIN:08714729904588 |
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 | 13 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.
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510(K) Database | 510(K)s with Product Code = PCU
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