Z-1689-2025Class II

IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert...

Name: Z-1689-2025 IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert...
Creator: Boston Scientific Corporation
Published: 2025-03-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2025-03-24 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of 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... on 2025-03-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1689-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-24
Posted: 2025-04-29
Recalling firm: Boston Scientific Corporation
Product: 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 code: GEH Unit, Cryosurgical, Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] (email) or Fax to: Field Action Center 1-763-415-7708.
Quantity in commerce: 67 units
Distribution: Nationwide
Product codes and lots: GTIN00191506032708, Batch Numbers: 33988638, 33988639, 34309895, 34309896, 34392269, 34392270, 34392271, 34564920.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1689-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1686-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-29
Z-1687-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-29
Z-1688-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-29
Z-1689-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-29

Product code GEH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)