Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0679-2021·Announced 2020-12-30

Boston Scientific Recalls IceRod 1.5 MRI Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 772 IceRod 1.5 MRI Cryoablation Needles 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, significant injuries, or deaths, fitting the criteria for a moderate severity recall involving a potential defect without confirmed severe harm.

Plain-English summary

Boston Scientific Corporation is recalling 772 units of the IceRod 1.5 MRI 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 involves specific units identified by the UPN FPRPR3193 and UDI 7290104830273. The affected batch numbers include U1440, U1441, U1311, U1312, U1015, U1016, U0462, U0461, U0050, U0030, T0520, T0521, T0157, T0158, A7135, A7134, A6987, A6986, A6707, A6708, A6689, A6688, A1730, A1731, A1149, and A1150.

Healthcare providers and facilities should check their inventory for these specific lot numbers and contact Boston Scientific for instructions on how to return the affected devices.

The recalled product

Product: IceRod" 1.5 MRI Cryoablation Needle¿
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cryoablation Needle
Hazard: gas-leak
Affected units: 772

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: FPRPR3193 UDIs: 7290104830273
7290104830273
7290104830273 Batch Numbers: U1440
U1441
U1311
U1312
U1015
U1016
U0462
U0461
U0050
U0030
T0520
T0521
T0157
T0158
A7135
A7134
A6987
A6986

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