The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0666-2021·Announced 2020-12-30

Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

Boston Scientific is recalling 4,645 IceRod 1.5 PLUS 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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. The hazard involves a functional defect (gas leak) in a medical device used for cryoablation, which poses a risk of harm if the device fails during a procedure, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Boston Scientific Corporation is recalling 4,645 units of the IceRod" 1.5 PLUS 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 recall includes specific batch numbers and is identified by the FDA recall number Z-0666-2021. The agency has classified this recall as Class II. The source text does not provide specific dates of distribution or specific instructions for consumers beyond the recall notice itself.

The recalled product

Product
IceRod" 1.5 PLUS 90¿ Cryoablation Needle
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cryoablation Needle
Hazard
Affected units
4,645

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: FPRPR3508 UDIs: 7290104830563
  • 7290104830563
  • 7290104830563 Batch Numbers: U1442
  • U1443
  • U1435
  • U1434
  • U1371
  • U1372
  • U1360
  • U1361
  • U1020
  • U1038
  • U1019
  • U1017
  • U1018
  • U0436
  • U0392
  • U0373
  • U0372
  • U0327

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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