Agency classClass IIOur severity:High FDA (Devices)·Z-0683-2021·Announced 2020-12-30

Boston Scientific Recalls IcePearl Prostate Cryoablation Kits Due to Gas Leaks

Boston Scientific is recalling 215 IcePearl 2.1 CX 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. The hazard involves a gas leak in a medical device used for prostate treatment, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Boston Scientific Corporation is recalling 215 units of the IcePearl 2.1 CX 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 specify the exact dates of distribution or the specific batch numbers involved, though the structured data lists various batch identifiers. No specific instructions for consumers are provided in the source text beyond the recall notice itself.

The recalled product

Product: IcePearl" 2.1 CX Prostate Cryoablation Kit
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Urological
Hazard: gas-leak
Affected units: 215

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: FPRPR3606 UDIs: 7290104831041
7290104831041
7290104831041 Batch Numbers: U1473
U1299
U1300
U1261
U1213
U1109
U1039
U1031
U0925
U0924
U0858
U0784
U0614
U0613
U0582
U0554
U0226
U0227

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