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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 FirmMarch 24, 2025
Date PostedApril 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1686-2025
Recall Event ID 96556
510(K)NumberK232635 
Product Classification Unit, cryosurgical, accessories - Product Code GEH
ProductIceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Code Information GTIN 00191506032678, Batch Numbers: 33744602, 33744603, 33744604, 33744605, 33931901, 33937786, 33937787, 33942987, 33942988, 33942989, 33950417, 33950418, 33996423, 33996424, 33996428, 34038291, 34038292, 34038307, 34117281, 34128141, 34128142, 34151877, 34151878, 34204928, 34204929, 34256930, 34256931, 34256932, 34295233.
FEI Number 3002095335
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactClara Johnson
763-494-1133
Manufacturer Reason
for Recall		Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
FDA Determined
Cause 2		Process control
ActionBoston Scientific issued a Product Advisory notice to its consignees on 03/24/2025 via Fed Ex, email, and hand delivery. The notice explained the issue, clinical impact, and provided the following recommendations: " Avoid disconnecting and reconnecting these IceSeed CX Cryoablation Needles from/to the Cryoablation System. " Maintain initial connection of IceSeed CX Cryoablation Needles to the Cryoablation System and the IceSeed CX Cryoablation Needles will perform as intended. The consignee was also directed to immediately post this information in a visible location near the affected products to ensure it 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 entities where the affected devices may have been transferred and complete the acknowledgement form and return it to BSCFieldActionCenter@bsci.com (email) or Fax to: Field Action Center 1-763-415-7708.
Quantity in Commerce435 units
DistributionNationwide
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 = GEH
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