High FDA (Devices)·Z-0666-2021·Announced 2020-12-30

Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 4,645 IceRod 1.5 PLUS 90° Cryoablation Needles nationwide because of 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 is classified as FDA Class II. The hazard involves a functional defect (gas leak) in a medical device used for cryoablation, which poses a risk of harm if the device fails during a procedure, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Boston Scientific Corporation is recalling 4,645 units of the IceRod" 1.5 PLUS 90° Cryoablation Needle. The recall is being conducted due to a complaint trend regarding gas leaks in the needle shaft. The affected products were distributed nationwide.

The recall includes specific batch numbers and is identified by the FDA recall number Z-0666-2021. The agency has classified this recall as Class II. The source text does not provide specific dates of distribution or specific instructions for consumers beyond the recall notice itself.

The recalled product

Product: IceRod" 1.5 PLUS 90¿ Cryoablation Needle
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cryoablation Needle
Hazard: gas-leak
device-failure
Affected units: 4,645

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: FPRPR3508 UDIs: 7290104830563
7290104830563
7290104830563 Batch Numbers: U1442
U1443
U1435
U1434
U1371
U1372
U1360
U1361
U1020
U1038
U1019
U1017
U1018
U0436
U0392
U0373
U0372
U0327

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