The Recall Desk
HighFDA (Devices)·Z-0686-2021·Announced 2020-12-30

Boston Scientific Recalls IceRod i-Thaw Prostate Cryoablation Kits Due to Gas Leaks

Boston Scientific is recalling 947 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 source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 947 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 includes specific units identified by UPN FPRPR3572 and UDI 7290104830983. The source text lists numerous batch numbers associated with the recalled units, including U1423, U1422, U1329, and others. The agency has classified this recall as Class II.

Healthcare providers and patients should stop using the affected kits and contact Boston Scientific Corporation for further instructions or a replacement. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
IceRod" i-Thaw" Prostate Cryoablation Kit
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Prostate Cryoablation
Hazard
Affected units
947

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: FPRPR3572 UDIs: 7290104830983
  • 7290104830983
  • 7290104830983 Batch Numbers: U1423
  • U1422
  • U1329
  • U1227
  • U1091
  • U1128
  • U1127
  • U1090
  • U0976
  • U1011
  • U0919
  • U0917
  • U0868
  • U0869
  • U0738
  • U0739
  • U0403
  • U0404

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

Same manufacturer · Boston Scientific Corporation

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Same hazard · gas leak

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