CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report
IceSeed 1.5 CX Needle OUS, Cryoablation Needle recalled
Boston Scientific is recalling IceSeed 1.5 CX Needle OUS, Cryoablation Needle, distributed nationwide in the US. The recall was initiated on 24 Mar 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1689-2025
- FDA event ID
- 96556
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Mar 2025
- FDA classified
- 29 Apr 2025
- Reported
- 7 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Temperature Abuse
- Device type
- Syringes & Needles
Timeline
| 24 Mar 2025 | Recall initiated by company | |
| 29 Apr 2025 | Classified by FDA | +36 days |
| 7 May 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it 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.
Which lots are affected?
GTIN00191506032708, Batch Numbers: 33988638, 33988639, 34309895, 34309896, 34392269, 34392270, 34392271, 34564920.
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 96556This product is part of a recall event; the main page for the event is IceSeed 1.5 CX S Needle OUS, Cryoablation Needle recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | IceSeed 1.5 CX S Needle OUS, Cryoablation Needle recalled | Boston Scientific | Temperature Abuse | Nationwide | |
| CLASS II | IceSeed 1.5 CX S Needle US, Cryoablation Needle recalled | Boston Scientific | Temperature Abuse | Nationwide | |
| CLASS II | IceSeed 1.5 CX Needle US, Cryoablation Needle recalled | Boston Scientific | Temperature Abuse | Nationwide |
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