Agency classClass IIOur severity:High FDA (Devices)·Z-0657-2021·Announced 2020-12-30

Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 22,289 IceFORCE 2.1 CX 90° Cryoablation Needles nationwide because of 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 and involves a functional defect (gas leaks) in a medical device used for cryoablation, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Boston Scientific Corporation is recalling 22,289 units of the IceFORCE 2.1 CX 90° Cryoablation Needle. The recall is being conducted due to a complaint trend regarding gas leaks in the needle shaft.

The affected devices were distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration. Specific lot numbers and batch codes are listed in the official recall documentation.

Healthcare providers and patients should stop using the affected needles and contact Boston Scientific for instructions on return or replacement.

The recalled product

Product: IceFORCE" 2.1 CX 90¿ Cryoablation Needle
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cryoablation Needle
Hazard: gas-leak
Affected units: 22,289

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: FPRPR3602 UDIs: 7290104831003
7290104831003
7290104831003 Batch Numbers: U1397
U1395
U1359
U1357
U1396
U1394
U1355
U1353
U1351
U1349
U1347
U1338
U1340
U1342
U1344
U1346
U1348
U1354

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