The Recall Desk
HighFDA (Devices)·Z-0661-2021·Announced 2020-12-30

Boston Scientific Recalls IcePearl Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 86 IcePearl 2.1 CX Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

What this means for you

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. The hazard involves a functional defect (gas leak) in a medical device used for cryoablation, which poses a risk of harm if the procedure fails, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Boston Scientific Corporation is recalling 86 units of the IcePearl 2.1 CX Cryoablation Needle. The recall is being conducted due to a complaint trend regarding gas leaks in the needle shaft.

The affected products were distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration. Specific batch numbers and Unique Device Identifiers (UDIs) for the affected units are listed in the official recall documentation.

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

The recalled product

Product
IcePearl" 2.1 CX Cryoablation Needle
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cryoablation Needle
Hazard
Affected units
86

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 (19)

  • UPN: FPRPR3603 UDIs: 7290104831010
  • 7290104831010
  • 7290104831010 Batch Numbers: U0902
  • U0786
  • U0646
  • U0558
  • U0041
  • T0269
  • T0137
  • T0138
  • T0056
  • T0025
  • A7015
  • A6929
  • A6908
  • A6723
  • A1564
  • A1521
  • A1249

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

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Same hazard · gas leak

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