Z-1686-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2025
- Initiation Date
- March 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 435 units
Product Description
IceSeed 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.
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.
Distribution Pattern
Nationwide
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.