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U.S. Department of Health and Human Services

Class 2 Device Recall NaviFlex" Pusher

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 Class 2 Device Recall NaviFlex" Pushersee related information
Date Initiated by FirmSeptember 10, 2026
Date PostedOctober 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0143-2027
Recall Event ID 99829
510(K)NumberK223592 
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
ProductNaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Code Information Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;
FEI Number 3005099803
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactRenee Archie
508-683-4523
Manufacturer Reason
for Recall		Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn September 10, 2026, Urgent Medical Device Removal letters were sent to customers. Actions to be taken: 1. Immediately stop further use or distribution and segregate affected product (see Attachment 1 for identification of the affected devices). 2. Continue to follow the standard of care when monitoring patients treated with the product. 3. Complete and return the enclosed Reply Verification Tracking Form per the included instructions. 4. Return product to Boston Scientific in accordance with the enclosed instructions. 97657220-FA Advanix Pancreatic LW Pusher. 5. Forward this notice to relevant personnel and any facilities to which the product was transferred.
Quantity in Commerce403
DistributionUS Nationwide distribution in the states of AL, CA, FL, GA, IL, IN, KY, MD, NC, NH, NM, NY, RI, TX, WA, WI, WV and the countries in TBD.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FGE
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