IceSeed 1.5 CX Cryoablation Needles Recalled for Incorrect Software Settings
Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 due to incorrect software programming. Affected needles may prompt unnecessary Needle Integrity and Functionality Tests if disconnected and reconnected during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 software configuration error. The source explicitly states the needles "perform as intended" during normal use, and there are no reported illnesses or injuries. The hazard is a workflow/functionality issue that does not create direct patient harm, fitting the Moderate category for non-critical device configuration errors.
Plain-English summary
Boston Scientific Corporation is recalling IceSeed 1.5 CX cryoablation needles (REF H7493967534170) manufactured between April 2024 and February 2025. The needles have been programmed with DEMO settings instead of Commercial settings. Approximately 67 units were distributed nationwide, with batch numbers 33988638, 33988639, 34309895, 34309896, 34392269, 34392270, 34392271, and 34564920.
The affected needles perform as intended when initially connected to the Cryoablation System and tested per standard protocols. However, if a needle is disconnected and reconnected to any channel after the initial test, the Cryoablation System will prompt re-execution of the Needle Integrity and Functionality Test (NIT). This unexpected re-prompting may cause confusion or workflow disruption during clinical use.
Users of potentially affected needles should verify the batch numbers against the Affected Product Listing. Boston Scientific has not reported any injuries or adverse events associated with this issue. Clinicians should consult the company's guidance for questions about needle lot compatibility.
The recalled product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 67
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)
- GTIN00191506032708
- Batch Numbers: 33988638
- 33988639
- 34309895
- 34309896
- 34392269
- 34392270
- 34392271
- 34564920.
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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