The Recall Desk
HighFDA (Devices)·Z-0658-2021·Announced 2020-12-30

Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 75 units of IceFORCE 2.1 CX Cryoablation Needles nationwide due to 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, and the hazard involves a functional defect (gas leak) in a medical device used for cryoablation, which poses a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Boston Scientific Corporation is recalling 75 units of the IceFORCE 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 involves specific units identified by the Universal Product Name (UPN) FPRPR3604 and specific Universal Device Identifiers (UDIs) and batch numbers listed in the agency's official records. The source text does not specify the exact dates of distribution or the specific medical facilities where the products were shipped.

Healthcare providers and patients should stop using the affected needles immediately. Boston Scientific is the firm responsible for the recall and will manage the retrieval of the devices. No specific instructions for consumers are provided in the source text beyond the identification of the defect.

The recalled product

Product
IceFORCE" 2.1 CX Cryoablation Needle
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cryoablation Needle
Hazard
Affected units
75

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 (17)

  • UPN: FPRPR3604 UDIs: 7290104831027
  • 7290104831027
  • 7290104831027 Batch Numbers: U0903
  • U0785
  • U0617
  • U0042
  • T0166
  • T0156
  • A7083
  • A6931
  • A6928
  • A6916
  • A6734
  • A1549
  • A1527
  • X1483
  • A1203

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

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