The Recall Desk
HighFDA (Devices)·Z-0673-2021·Announced 2020-12-30

Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 92 units of IceSphere 1.5 90° Cryoablation Needles 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 describes a functional defect (gas leaks) in a medical device without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 92 units of the IceSphere 1.5 90° Cryoablation Needle. The recall is being conducted due to a complaint trend regarding gas leaks in the needle shaft.

The affected products were distributed nationwide. The specific units involved are identified by the following batch numbers: U0326, U0325, U0286, U0285, A7012, and A7011. The Universal Product Number (UPN) is FPRPR3260, and the associated Unique Device Identifier (UDI) is 07290104830259.

Healthcare providers and facilities should check their inventory for these specific batch numbers and stop using the affected needles. Boston Scientific is the recalling firm responsible for managing this recall.

The recalled product

Product
IceSphere" 1.5 90¿ Cryoablation Needle
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cryoablation Needle
Hazard
Affected units
92

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 (8)

  • UPN: FPRPR3260 UDIs: 07290104830259
  • 07290104830259
  • 07290104830259 Batch Numbers: U0326
  • U0325
  • U0286
  • U0285
  • A7012
  • A7011

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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