The Recall Desk
HighFDA (Devices)·Z-0676-2021·Announced 2020-12-30

Boston Scientific Recalls IceSeed 1.5 Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 152 IceSeed 1.5 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 hazard involves a functional defect (gas leak) 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 152 units of the IceSeed 1.5 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 recall includes specific units identified by UPN FPRPR3201 and UDI 7290104830181. The affected batch numbers are U0181, T0393, A6912, A6664, A1915, A1072, A1024, A0853, and A0574. The source text does not specify the exact dates of distribution or the specific facilities where these units were used.

Healthcare providers and patients should stop using the affected needles 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
IceSeed" 1.5 Cryoablation Needle
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cryoablation Needle
Hazard
Affected units
152

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 (11)

  • UPN: FPRPR3201 UDIs: 7290104830181
  • 7290104830181
  • 7290104830181 Batch Numbers: U0181
  • T0393
  • A6912
  • A6664
  • A1915
  • A1072
  • A1024
  • A0853
  • A0574

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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