The Recall Desk
HighFDA (Devices)·Z-0685-2021·Announced 2020-12-30

Boston Scientific Recalls Prostate Cryoablation Kits Due to Gas Leaks

Boston Scientific is recalling 117 IcePearl 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 and involves a medical device defect (gas leaks) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 117 units of the IcePearl 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 is classified as Class II by the U.S. Food and Drug Administration. The source text does not specify reported injuries, illnesses, or fatalities associated with this defect. The specific batch numbers and UDI codes for the affected units are listed in the official recall documentation.

Healthcare providers and patients should stop using the affected kits and contact Boston Scientific Corporation for instructions on return or replacement. Consumers should verify the product details against the recall notice to determine if their specific unit is affected.

The recalled product

Product
Three IcePearl" 2.1 CX Prostate Cryoablation Kit
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Urological
Hazard
Affected units
117

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: FPRPR3608 UDIs: 7290104831065
  • 7290104831065
  • 7290104831065 Batch Numbers: U1308
  • U1304
  • U1066
  • U1034
  • U0859
  • U0860
  • U0661
  • U0660
  • U0609
  • U0588
  • T0815
  • T0816
  • T0270
  • T0238
  • T0212
  • T0211
  • T0181
  • T0144

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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