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U.S. Department of Health and Human Services

Class 2 Device Recall Autotome RX

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 Class 2 Device Recall Autotome RXsee related information
Date Initiated by FirmJune 12, 2024
Date PostedJuly 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2350-2024
Recall Event ID 94827
510(K)NumberK013153 
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
ProductAutotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Code Information UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027
FEI Number 3005099803
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactRebecca KinKead Rubio
508-683-4000
Manufacturer Reason
for Recall		Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
FDA Determined
Cause 2		Process control
ActionAll customers notified via courier on June 12, 2024 - notice was titled "Urgent Medical Device Removal." Customers were informed to cease further use or distribution of any remaining affected product. Product should be segregated and returned to the firm. For more information, please reach out to your local Boston Scientific representative.
Quantity in Commerce256 US, 39 OUS
DistributionDomestic distribution nationwide.
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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