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.
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: 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.
See all 37 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · gas leak
See all →- Severe
- High
- SeverePar Nado Alto Travel Trailers Recalled for Gas Leak Risk
NHTSA · 2025-10-31
- HighHeil Recalls Side Loader Garbage Trucks Due to Fuel Leak Risk
NHTSA · 2025-10-31
- High
Similar recalls
- HighBoston Scientific Recalls Prostate Cryoablation Kits Due to Needle Surface Deterioration
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls Prostate Cryoablation Kits Due to Needle Deterioration
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls IcePearl 2.1 CX Prostate Kit Due to Needle Deterioration
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls IceFORCE Prostate Kit Due to Needle Surface Deterioration
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration
FDA (Devices) · 2020-07-29
- HighBoston Scientific Recalls IceFORCE Cryoablation Needles Due to Surface Deterioration
FDA (Devices) · 2020-07-29