The Recall Desk
HighFDA (Devices)·Z-0672-2021·Announced 2020-12-30

Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 729 IceSphere 1.5 S 90° Cryoablation Needles 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 the hazard involves a functional defect (gas leaks) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Boston Scientific Corporation is recalling 729 units of the IceSphere 1.5 S 90° Cryoablation Needle. 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 the UPN FPRPR3561 and various batch numbers, including U1176, U1175, U0460, U0459, U0157, T0702, T0389, T0390, T0371, T0370, T0064, T0065, T0045, T0044, A7075, A7074, A6873, A6872, A1632, A1633, A1616, A1615, A1363, and A1364.

Healthcare providers and consumers should check their inventory for these specific lot numbers and contact Boston Scientific Corporation for instructions on how to return or replace the affected devices.

The recalled product

Product
IceSphere" 1.5 S 90¿ Cryoablation Needle
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cryoablation Needle
Hazard
Affected units
729

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: FPRPR3561 UDIs: 7290104830556
  • 7290104830556
  • 7290104830556 Batch Numbers: U1176
  • U1175
  • U0460
  • U0459
  • U0157
  • T0702
  • T0389
  • T0390
  • T0371
  • T0370
  • T0064
  • T0065
  • T0045
  • T0044
  • A7075
  • A7074
  • A6873
  • A6872

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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