Agency classClass IIOur severity:High FDA (Devices)·Z-0664-2021·Announced 2020-12-30

Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 6,363 IceSphere 1.5 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 leak) in a medical device where no injuries have been reported, fitting the criteria for a risk-of-harm product without reported injury.

Plain-English summary

Boston Scientific Corporation is recalling 6,363 units of the IceSphere 1.5 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. The source text does not report any specific illnesses or injuries associated with this defect. Consumers and healthcare providers should check their inventory for the specific batch numbers and UDI codes listed in the official recall notice and contact Boston Scientific for instructions on how to return or replace the devices.

The recalled product

Product: IceSphere" 1.5 CX 90¿ Cryoablation Needle
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cryoablation Needle
Hazard: gas-leak
Affected units: 6,363

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: FPRPR3573 UDIs: 7290104831133
7290104831133
7290104831133 Batch Numbers: U1458
U1457
U1459
U1460
U1461
U1429
U1428
U1426
U1427
U1425
U1430
U1333
U1331
U1232
U1230
U1334
U1332
U1335

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

See all →

Severe
Boston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
Moderate
Boston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09

Same hazard · gas leak