Boston Scientific Recalls IceSeed Prostate Cryoablation Kits Due to Gas Leaks
Boston Scientific is recalling 211 IceSeed Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.
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: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, aligning with the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling 211 units of the IceSeed Prostate Cryoablation Kit. The recall is being conducted due to a complaint trend regarding needle shaft gas leaks. The affected products were distributed nationwide.
The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific injuries, illnesses, or deaths associated with this defect. The specific lot numbers and UDI codes for the affected units are listed in the official recall documentation.
The recalled product
- Product
- IceSeed" Prostate Cryoablation Kit
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 211
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)
- UPN: FPRPR4518 UDIs: 7290104830075
- 7290104830075
- 7290104830075 Batch Numbers: U1262
- U1114
- U1036
- U0910
- U0909
- U0863
- U0365
- U0280
- U0281
- U0180
- U0088
- U0038
- T0529
- T0457
- T0235
- T0178
- T0058
- A6911
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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