High FDA (Devices)·Z-0693-2021·Announced 2020-12-30

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.

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 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
Category: Medical Device — Surgical Instrument
Hazard: gas-leak
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.

See all 37 products in this recall →

Same manufacturer · Boston Scientific Corporation

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Same hazard · gas leak