—#213157

Product

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.

FDA product code: GEH — Unit, Cryosurgical, Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K232635
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

Boston 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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2025-03-24
Posted by FDA: 2025-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213157. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.