Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0677-2021·Announced 2020-12-30

IceEDGE Cryoablation Needle gas leak recall issued by FDA

Boston Scientific Corporation recalled 525 IceEDGE cryoablation needles due to reported gas leaks in the needle shaft, affecting nationwide distribution.

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 involves a mechanical defect (gas leaks in the needle shaft) but no injuries or fatalities have been reported. According to the severity rubric, such cases fall under 'Minor labeling errors, low-risk contamination, voluntary precautionary recalls' which corresponds to a Moderate (Score 2) rating.

Plain-English summary

The U.S. Food and Drug Administration issued recall Z-0677-2021 for 525 units of the IceEDGE 2.4° 90p° Cryoablation Needle manufactured by Boston Scientific Corporation. The recall addresses a complaint trend indicating gas leaks in the needle shaft, which may affect device performance during use. The product was distributed nationwide and requires consumer action to obtain replacement parts or return the devices.

Consumers who purchased these needles should contact their healthcare provider or the manufacturer to arrange for replacement. The recall is voluntary and does not involve immediate life-threatening risks, but the gas leak issue represents a potential safety concern for the intended medical procedure. The FDA recommends that affected patients discontinue use until further evaluation and provide feedback through the recall notification process.

The recalled product

Product: IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cryoablation Needle
Hazard: gas-leak
Affected units: 525

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: FPRPR3506 UDIs: 7290104830594
7290104830594
7290104830594 Batch Numbers: U0288
U0287
U0062
U0060
T0433
T0434
T0416
T0417
X6836
A6781
A6782
A6762
A6761
A2078
A2079
A1529
A1373
A1374

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