Cryoablation Needles Recalled for Incorrect Programming Settings
Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured April 2024 to February 2025 due to DEMO settings instead of COMMERCIAL settings. Affected needles may prompt unexpected re-testing if disconnected and reconnected after initial use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a programming defect affecting normal operation following disconnect/reconnect cycles. No injuries or illnesses have been reported, but the incorrect settings represent a risk-of-harm for a surgical device where unexpected behavior could disrupt clinical workflow and patient safety protocols.
Plain-English summary
Boston Scientific Corporation is recalling the IceSeed 1.5 CX cryoablation needle (REF H7493967534170) manufactured between April 2024 and February 2025. Approximately 67 units were distributed nationwide.
These needles were programmed with DEMO settings instead of COMMERCIAL settings. Upon initial connection to a Cryoablation System, the needles perform as intended and pass the standard Needle Integrity and Functionality Test (NIT) per protocol. However, if a needle is disconnected and reconnected to any channel after initial testing, the Cryoablation System will prompt for re-execution of the NIT, which represents a deviation from expected behavior.
Affected batch numbers are: 33988638, 33988639, 34309895, 34309896, 34392269, 34392270, 34392271, and 34564920. The GTIN is 00191506032708. Healthcare facilities should verify whether they have received any affected units and consult with Boston Scientific for guidance on replacement or return procedures.
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
- Hazard
- device-malfunction
- incorrect-settings
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.
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