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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific

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 Class 2 Device Recall Boston Scientificsee related information
Date Initiated by FirmDecember 20, 2024
Date PostedJanuary 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1032-2025
Recall Event ID 96049
510(K)NumberK233318 
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
ProductHOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
Code Information GTIN: 08714729904540 Lot Numbers: 33336402, 33336404, 33336405, 33336411, 33392916, 33392917, 33393302, 33411607, 33437479, 33548501, 33577903, 33704371, 33712822, 33986537, 34017087, 34017088, 34017089, 34028458, 34065579, 34065660, 34083271, 34083272
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactSAME
508-683-4000
Manufacturer Reason
for Recall		Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
FDA Determined
Cause 2		Process control
ActionBoston Scientific issued Urgent Medical Device Removal - Immediate Action Required Letter via Fedex Priority Overnight on December 20, 2024 to US consignees. Letter states reason for recall, health risk and action to take: This removal affects only the products listed in Attachment 1. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Contact your local Boston Scientific representative with any questions.
Quantity in Commerce263 units (OUS)
DistributionNationwide including Puerto Rico Foreign: To be provided
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 = KNS
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