The Recall Desk
HighFDA (Devices)·Z-0684-2021·Announced 2020-12-30

Boston Scientific Recalls IceFORCE Prostate Cryoablation Kits Due to Gas Leaks

Boston Scientific is recalling 140 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 a surgical procedure, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Boston Scientific Corporation is recalling 140 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 specific units involved are identified by UPN FPRPR3607 and UDI 7290104831058, along with a list of specific batch numbers including U1302, U1303, and others.

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

The recalled product

Product
Three IceFORCE" 2.1 CX Prostate Cryoablation Kit
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Surgical Instrument
Hazard
Affected units
140

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: FPRPR3607 UDIs: 7290104831058
  • 7290104831058
  • 7290104831058 Batch Numbers: U1302
  • U1303
  • U1301
  • U1032
  • U0616
  • U0590
  • U0589
  • U0583
  • U0540
  • U0363
  • U0318
  • U0083
  • T0552
  • T0163
  • T0154
  • A6915
  • A6849
  • A6848

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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