Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-1689-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

Product Classification:

Class II

Date Initiated: March 24, 2025

Date Posted: May 7, 2025

Recall Number: Z-1689-2025

Event ID: 96556

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.

Status: Ongoing

Product Quantity: 67 units

Code Information:

GTIN00191506032708, Batch Numbers: 33988638, 33988639, 34309895, 34309896, 34392269, 34392270, 34392271, 34564920.

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated