The Recall Desk
HighFDA (Devices)·Z-0667-2021·Announced 2020-12-30

Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 255 IceRod 1.5 PLUS 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 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 255 units of the IceRod 1.5 PLUS 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 involves specific units identified by the UPN FPRPR3510 and UDI 7290104830570. The affected batch numbers include U1021, U1022, U1014, U1013, U0780, U0781, U0391, U0214, U0008, A2081, A2080, and A1531.

Healthcare providers and facilities should check their inventory for these specific product codes and batch numbers. If the product is found, it should be removed from use and returned to Boston Scientific Corporation according to the recall instructions.

The recalled product

Product
IceRod" 1.5 PLUS Cryoablation Needle
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cryoablation Needle
Hazard
Affected units
255

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 (14)

  • UPN: FPRPR3510 UDIs: 7290104830570
  • 7290104830570
  • 7290104830570 Batch Numbers: U1021
  • U1022
  • U1014
  • U1013
  • U0780
  • U0781
  • U0391
  • U0214
  • U0008
  • A2081
  • A2080
  • A1531

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

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Same hazard · gas leak

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