The Recall Desk
HighFDA (Devices)·Z-0682-2021·Announced 2020-12-30

Boston Scientific Recalls IceFORCE Prostate Cryoablation Kits Due to Gas Leaks

Boston Scientific is recalling 85 IceFORCE 2.1 CX Prostate Cryoablation Kits 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. The hazard involves a functional defect (gas leak) in a medical device used for invasive procedures, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Boston Scientific Corporation is recalling 85 units of the IceFORCE 2.1 CX Prostate Cryoablation Kit. The recall is being conducted due to a complaint trend regarding needle shaft gas leaks.

The affected products were distributed nationwide. The recall includes specific units identified by the UPN FPRPR3605 and various batch numbers, including U1030, U0904, and U0864.

Healthcare providers and consumers should stop using the affected kits and contact Boston Scientific Corporation for further instructions or a replacement.

The recalled product

Product
IceFORCE" 2.1 CX Prostate Cryoablation Kit
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Surgical Instruments
Hazard
Affected units
85

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: FPRPR3605 UDIs: 7290104831034
  • 7290104831034
  • 7290104831034 Batch Numbers: U1030
  • U0904
  • U0864
  • U0856
  • U0763
  • U0649
  • T0153
  • A7062
  • A7061
  • A6930
  • A6758
  • A1781
  • A1776
  • A1565
  • A1550
  • A1435
  • A1291

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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