Boston Scientific IceSeed CX Cryoablation Needles Incorrectly Programmed
Boston Scientific is recalling IceSeed 1.5 CX S cryoablation needles manufactured April 2024 to February 2025 that were programmed with DEMO instead of Commercial settings. If disconnected and reconnected after initial testing, the system will re-prompt testing rather than functioning normally.
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 medical device programming error. The source text explicitly states the needles "perform as intended" during standard use and initial testing, and no illnesses or injuries are reported. The issue only manifests if a needle is disconnected and reconnected after testing, making it a conditional malfunction without documented harm.
Plain-English summary
Boston Scientific Corporation is recalling IceSeed 1.5 CX S NEEDLE OUS cryoablation needles (REF H7493967334100) that were manufactured between April 2024 and February 2025. These needles have been programmed with DEMO settings instead of Commercial settings. The affected batch numbers are: 33996437, 33996438, 34295231, 34295232, 34392272, 34392273, 34392274, and 34564921. A total of 31 units have been identified nationwide.
The needles are intended to convert high-pressure gas to either a freezing or thawing application. Upon initial connection to the Cryoablation System, users are prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended during and after this initial test. However, if a needle is disconnected and reconnected to any channel after testing, the Cryoablation System will prompt re-execution of the NIT rather than proceeding with normal operation.
Boston Scientific advises healthcare facilities and users to identify needles from the affected batch numbers and contact the company or consult the FDA recall notice for further guidance.
The recalled product
- Product
- IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. 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
- Affected units
- 31
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 (9)
- GTIN 00191506032685
- Batch Numbers: 33996437
- 33996438
- 34295231
- 34295232
- 34392272
- 34392273
- 34392274
- 34564921.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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