FDA Device recall Z-1688-2025
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170
- FDA Device
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170 by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1688-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-24 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Reason
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.
Identifiers
| code_info | GTIN 00191506032692, Batch Numbers: 33744276, 33744277, 33744278, 33744600, 33931638, 33931639, 33931900, 33980480, 33…GTIN 00191506032692, Batch Numbers: 33744276, 33744277, 33744278, 33744600, 33931638, 33931639, 33931900, 33980480, 33980481, 33980482, 33989380, 33989381, 33989382, 34063066, 34063067, 34063068, 34063069, 34063070, 34084080, 34084081, 34084084, 34094111, 34094112, 34110333, 34110334, 34110335, 34110336, 34110337, 34168777, 34168778, 34204925, 34204926, 34204927, 34295709. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1688-2025%22
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