Boston Scientific Recalls IceRod 1.5 Cryoablation Needles Due to Gas Leaks
Boston Scientific is recalling 26 units of IceRod 1.5 Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
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: The recall is classified as FDA Class II and involves a functional defect (gas leak) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Boston Scientific Corporation is recalling 26 units of the IceRod 1.5 Cryoablation Needle. The recall is being conducted due to a complaint trend regarding gas leaks in the needle shaft.
The affected products were distributed nationwide. The specific units are identified by UPN FPRPR3203 and Batch Numbers U0382, A6775, A1875, and A0575. The Unique Device Identifiers (UDIs) for these units are 07290104830198.
This recall is classified as Class II by the U.S. Food and Drug Administration. Healthcare providers and facilities should stop using the affected needles and contact Boston Scientific for further instructions.
The recalled product
- Product
- IceRod" 1.5 Cryoablation Needle
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 26
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 (6)
- UPN: FPRPR3203 UDIs: 07290104830198
- 07290104830198
- 07290104830198 Batch Numbers: U0382
- A6775
- A1875
- A0575
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 37 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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