The Recall Desk
HighFDA (Devices)·Z-0691-2021·Announced 2020-12-30

Boston Scientific Recalls Prostate Cryoablation Kits Due to Gas Leaks

Boston Scientific is recalling 243 IceRod i-Thaw Prostate Cryoablation Kits 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 and involves a functional defect (gas leaks) in a medical device used for surgery, 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 243 units of the 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 is classified as Class II by the U.S. Food and Drug Administration. The source text does not specify any reported injuries, illnesses, or deaths associated with this defect. The specific batch numbers and UDI codes for the affected units are listed in the official recall documentation.

Consumers who have this product should contact Boston Scientific Corporation for instructions on how to return or replace the device. The recall number for this action is Z-0691-2021.

The recalled product

Product
IceRod" i-Thaw" Prostate Cryoablation Kit
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Surgical Instrument
Hazard
Affected units
243

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: FPRPR4070 UDIs: 7290104830105
  • 7290104830105
  • 7290104830075
  • 7290104830099
  • 7290104830105 Batch Numbers: U1363
  • U0865
  • U0555
  • U0542
  • U0151
  • U0150
  • U0054
  • U0053
  • U0046
  • U0037
  • U0036
  • T0633
  • T0515
  • T0430
  • T0274
  • T0273

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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