High FDA (Devices)·Z-0668-2021·Announced 2020-12-30

Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 93 units of IceRod 1.5 90° Cryoablation Needles 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 is classified as FDA Class II and involves a functional defect (gas leaks) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Boston Scientific Corporation is recalling 93 units of the IceRod 1.5 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 recalled products are identified by the following codes: UPN FPRPR3204, UDI 7290104830242, and batch numbers U0495, U0498, U0496, U0497, U0420, A0902, and A0903. This recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare providers and facilities should stop using the affected needles and contact Boston Scientific for further instructions on the recall process.

The recalled product

Product: IceRod" 1.5 90¿ Cryoablation Needle
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cryoablation Needle
Hazard: gas-leak
Affected units: 93

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 (9)

UPN: FPRPR3204 UDIs: 7290104830242
7290104830242
7290104830242 Batch Numbers: U0495
U0498
U0496
U0497
U0420
A0902
A0903

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