High FDA (Devices)·Z-0678-2021·Announced 2020-12-30

Boston Scientific Recalls IceRod MRI Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 3,894 IceRod 1.5 MRI 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. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).

Plain-English summary

Boston Scientific Corporation is recalling 3,894 units of the IceRod 1.5 MRI 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 is classified as Class II by the U.S. Food and Drug Administration. The source text does not specify reported injuries, illnesses, or fatalities associated with this defect. The specific batch numbers and UDI codes for the affected units are listed in the official recall documentation.

The recalled product

Product: IceRod" 1.5 MRI 90¿ Cryoablation Needle¿
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cryoablation Needle
Hazard: gas-leak
Affected units: 3,894

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: FPRPR3195 UDIs: 7290104830297
7290104830297
7290104830297 Batch Numbers: U1406
U1407
U1370
U1369
U1041
U1042
U0611
U0610
U0501
U0419
U0447
U0444
U0418
U0322
U0323
U0211
U0243
U0244

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