IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure

FDA device recall Z-1687-2025 · posted 2025-04-29 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

GEH

Quantity affected

31 units

Distribution

Nationwide

Date initiated

2025-03-24

Date posted

2025-04-29

Location

Maple Grove, MN