IceSeed 1.5 CX S Cryoablation Needle Programmed with Incorrect Settings
Boston Scientific is recalling 435 IceSeed 1.5 CX S cryoablation needles manufactured between April 2024 and February 2025 that were programmed with DEMO settings instead of Commercial settings, which can cause the Cryoablation System to prompt repeated tests if the needle is disconnected and reconnected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a configuration error that causes an inconvenient system behavior (repeated test prompts upon reconnection) rather than a direct safety hazard. The source text does not report any illnesses, injuries, or deaths, and the device functions as intended on initial connection. The issue is a setting-related inconvenience rather than a functional failure.
Plain-English summary
Boston Scientific Corporation is recalling IceSeed 1.5 CX S NEEDLE US cryoablation needles (REF H7493967233100) distributed nationwide. The affected needles were manufactured between April 2024 and February 2025 and contain DEMO settings instead of Commercial settings.
When an affected needle is first connected to the Cryoablation System, it performs as intended and prompts the standard Needle Integrity and Functionality Test (NIT) per protocol. However, if the needle is disconnected and reconnected to any channel after testing, the Cryoablation System will prompt re-execution of the NIT.
The recall affects 435 units across 29 batch numbers. Healthcare providers and patients should check their needle batch numbers against the affected batch list provided by Boston Scientific. If in possession of an affected needle, users should contact Boston Scientific for guidance on replacement or alternative steps.
The recalled product
- Product
- IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- mis-configuration
- firmware-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00191506032678
- Batch Numbers: 33744602
- 33744603
- 33744604
- 33744605
- 33931901
- 33937786
- 33937787
- 33942987
- 33942988
- 33942989
- 33950417
- 33950418
- 33996423
- 33996424
- 33996428
- 34038291
- 34038292
- 34038307
- 34117281
Distribution
Distributed nationwide across the United States.
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