The Recall Desk
HighFDA (Devices)·Z-0670-2021·Announced 2020-12-30

Boston Scientific Recalls IceSphere Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 2,429 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 hazard involves a functional defect (gas leak) in a medical device used for cryoablation, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Boston Scientific Corporation is recalling 2,429 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 devices were distributed nationwide. The recall includes specific batch numbers and UDI codes listed in the agency's structured data.

Healthcare providers and consumers should stop using the affected devices and contact Boston Scientific Corporation for further instructions or a replacement.

The recalled product

Product
IceSphere" 1.5 90¿ Cryoablation Needle
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cryoablation Needle
Hazard
Affected units
2,429

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: FPRPR3560 UDIs: 7290104830945
  • 7290104830945
  • 7290104830945 Batch Numbers: U1454
  • U1455
  • U1456
  • U1420
  • U1421
  • U1325
  • U1326
  • U1328
  • U1327
  • U0435
  • U0432
  • U0369
  • U0351
  • U0352
  • T0403
  • T0402
  • T0395
  • T0394

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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Same hazard · gas leak

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