Agency classClass IIOur severity:High FDA (Devices)·Z-0660-2021·Announced 2020-12-30

Boston Scientific Recalls IcePearl Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 8,453 IcePearl 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 the hazard involves a functional defect (gas leak) in a medical device used for cryoablation, which poses a risk of harm even though specific injuries are not detailed in the provided text.

Plain-English summary

Boston Scientific Corporation is recalling 8,453 units of the IcePearl 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, indicating a reasonable probability that the use of the device could cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should stop using the affected needles and contact Boston Scientific for further instructions or a replacement. The specific batch numbers and UDI codes for the affected units are listed in the official recall documentation.

The recalled product

Product: IcePearl" 2.1 CX 90¿ Cryoablation Needle
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cryoablation Needle
Hazard: gas-leak
device-malfunction
Affected units: 8,453

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: FPRPR3601 UDIs: 7290104830990
7290104830990
7290104830990 Batch Numbers: U1391
U1389
U1387
U1390
U1388
U1386
U1272
U1337
U1336
U1270
U1268
U1265
U1266
U1267
U1271
U1269
U1240
U1235

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