The Recall Desk
HighFDA (Devices)·Z-0687-2021·Announced 2020-12-30

Boston Scientific Recalls IceSeed Prostate Cryoablation Kits Due to Gas Leaks

Boston Scientific is recalling 52 IceSeed 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 procedure, which poses a risk of harm, but the source does not report specific injuries or hospitalizations, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 52 units of the IceSeed Prostate Cryoablation Kit. The recall is being conducted due to a complaint trend regarding needle shaft gas leaks. The affected products are identified by UPN FPRPR3008 and specific UDI and batch numbers listed in the agency record.

The affected units were distributed nationwide. The source text does not specify the exact dates of distribution or the specific facilities where the products were used.

Consumers and healthcare providers should stop using the affected kits and contact Boston Scientific Corporation for further instructions or a replacement.

The recalled product

Product
IceSeed" Prostate Cryoablation Kit
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Surgical Instruments
Hazard
Affected units
52

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 (13)

  • UPN: FPRPR3008 UDIs: 7290104830068
  • 7290104830068
  • 7290104830068 Batch Numbers: T0783
  • T0686
  • T0719
  • T0678
  • A6713
  • A6676
  • A2130
  • A2075
  • A1813
  • A1695
  • A1684

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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