Agency classClass IIOur severity:High FDA (Devices)·Z-0686-2021·Announced 2020-12-30

Boston Scientific Recalls IceRod i-Thaw Prostate Cryoablation Kits Due to Gas Leaks

Boston Scientific is recalling 947 IceRod i-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 is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 947 units of the IceRod i-Thaw 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 includes specific units identified by UPN FPRPR3572 and UDI 7290104830983. The source text lists numerous batch numbers associated with the recalled units, including U1423, U1422, U1329, and others. The agency has classified this recall as Class II.

Healthcare providers and patients should stop using the affected kits and contact Boston Scientific Corporation for further instructions or a replacement. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product: IceRod" i-Thaw" Prostate Cryoablation Kit
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Prostate Cryoablation
Hazard: gas-leak
Affected units: 947

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: FPRPR3572 UDIs: 7290104830983
7290104830983
7290104830983 Batch Numbers: U1423
U1422
U1329
U1227
U1091
U1128
U1127
U1090
U0976
U1011
U0919
U0917
U0868
U0869
U0738
U0739
U0403
U0404

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 →

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Same hazard · gas leak