Boston Scientific Recalls IceRod He-Thaw Prostate Cryoablation Kits
Boston Scientific is recalling 115 IceRod He-Thaw 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 3/5 (High).
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 involves a medical device with a functional defect (gas leaks) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 115 units of the IceRod" He-Thaw Prostate Cryoablation Kit. The recall is being conducted nationwide.
The recall was initiated due to a complaint trend regarding needle shaft gas leaks. The affected units are identified by UPN FPRPR4570 and specific UDI and batch numbers listed in the agency records.
No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the recalled product and the nature of the defect.
The recalled product
- Product
- IceRod" He-Thaw Prostate Cryoablation Kit
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 115
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: FPRPR4570 UDIs: 7290104830099
- 7290104830099
- 7290104830105
- 7290104830099 Batch Numbers:G5063
- G5871
- G5900
- G5902
- G5975
- P1901
- P2150
- P2204
- P2206
- P2207
- P2240
- P2241
- P2242
- P2243
- P2245
- P2247
- P2249
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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