IceSeed CX Cryoablation Needles Recalled for Demo Programming Issue
Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 because they were programmed with demo settings instead of commercial settings. If disconnected and reconnected during use, the system will prompt unnecessary recalibration testing.
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 with a firmware programming error. The source text explicitly states the affected needles "perform as intended" during normal use and no illnesses or injuries are reported. The issue is a reconnection scenario that prompts unnecessary recalibration, creating operational inconvenience rather than direct patient harm.
Plain-English summary
Boston Scientific Corporation is recalling IceSeed 1.5 CX NEEDLE US cryoablation needles (REF H7493967433170) due to incorrect firmware programming. The affected needles were manufactured between April 2024 and February 2025 and have been programmed with DEMO settings instead of Commercial settings. A total of 244 units were distributed nationwide under GTIN 00191506032692 across 34 batch numbers.
The affected needles function normally during initial connection to the Cryoablation System and pass the required Needle Integrity and Functionality Test (NIT) as expected. However, if a needle is disconnected and reconnected to any channel after initial testing, the Cryoablation System will prompt the user to re-execute the NIT instead of proceeding with the intended procedure.
Boston Scientific has issued this recall to inform users of the programming error. Healthcare providers using these needles should be aware of the reconnection behavior and follow standard protocols when using affected batch numbers. Refer to the Affected Product Listing for the complete list of batch numbers included in this recall.
The recalled product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- firmware-programming-error
- operational-disruption
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 00191506032692
- Batch Numbers: 33744276
- 33744277
- 33744278
- 33744600
- 33931638
- 33931639
- 33931900
- 33980480
- 33980481
- 33980482
- 33989380
- 33989381
- 33989382
- 34063066
- 34063067
- 34063068
- 34063069
- 34063070
- 34084080
Distribution
Distributed nationwide across the United States.
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