Agency classClass IIOur severity:High FDA (Devices)·Z-0688-2021·Announced 2020-12-30

Boston Scientific Recalls IceRod Prostate Cryoablation Kits Due to Gas Leaks

Boston Scientific is recalling 64 IceRod Prostate Cryoablation Kits nationwide because of 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 hazard involves a functional defect (gas leaks) in a medical device used for surgical procedures, representing a risk of harm where specific injury reports are not detailed in the source text.

Plain-English summary

Boston Scientific Corporation is recalling 64 units of the IceRod 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 involves specific units identified by UPN FPRPR3070 and UDI 7290104830082. The affected batch numbers are U0412, U0029, U0039, T0775, T0687, T0675, A1873, A1866, A1820, A1643, A1420, and A1226.

Healthcare providers and patients should stop using the affected kits and contact Boston Scientific Corporation for further instructions on returns or replacements.

The recalled product

Product: IceRod" Prostate Cryoablation Kit
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Surgical Instrument
Hazard: gas-leak
Affected units: 64

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 (14)

UPN: FPRPR3070 UDIs: 7290104830082
7290104830082
7290104830082 Batch Numbers: U0412
U0029
U0039
T0775
T0687
T0675
A1873
A1866
A1820
A1643
A1420
A1226

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