The Recall Desk
ModerateFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · Boston Scientific Corporation

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Same hazard · gas leak

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