The Recall Desk
HighFDA (Devices)·Z-0690-2021·Announced 2020-12-30

Boston Scientific Recalls Prostate Cryoablation Kits Due to Gas Leaks

Boston Scientific is recalling 178 IceRod i-Thaw 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, and the hazard involves a functional defect (gas leaks) in a medical device used for surgical procedures, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Boston Scientific Corporation is recalling 178 units of the Five IceRod" i-Thaw" 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 batch numbers and UDI codes, which are listed in the official agency documentation.

Healthcare providers and patients should stop using the affected kits and contact Boston Scientific Corporation for further instructions on replacement or refund.

The recalled product

Product
Five IceRod" i-Thaw" Prostate Cryoablation Kit
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Surgical Instrument
Hazard
Affected units
178

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: FPRPR3571 UDIs: 7290104830976
  • 7290104830976
  • 7290104830976 Batch Numbers: U1264
  • U1226
  • U1089
  • U1012
  • U1009
  • U0827
  • U0772
  • U0767
  • U0491
  • T0817
  • T0693
  • T0725
  • T0587
  • T0487
  • T0486
  • T0313
  • A7114
  • A6823

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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