The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2675-2020·Announced 2020-07-29

Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Surface Deterioration

Boston Scientific is recalling 18,440 IceFORCE 2.1 CX 90 Needle Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

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 surface deterioration of a surgical instrument, which poses a risk of harm during a procedure, but the source text does not report any specific injuries, hospitalizations, or deaths, placing it in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 18,440 units of the Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle. These prescription-only medical devices are intended for the cryoablative destruction of tissue during surgical procedures. The recall is being conducted because the needle surface deteriorated due to unexpected electrolysis during the procedure.

The affected devices were distributed nationwide to 48 states, the District of Columbia, and Canada. The recall includes specific batch numbers, which are listed in the official FDA record. No specific dates of distribution or sales are provided in the source text.

Healthcare providers and patients should stop using the affected devices and contact Boston Scientific Corporation for instructions on how to return or replace them. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Surgical Instrument
Hazard
Affected units
18,440

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: FPRPR3602
  • GTIN: 7290104831003
  • Batch: A0754
  • A0755
  • A0758
  • A0759
  • A0770
  • A0771
  • A0782
  • A0783
  • A0788
  • A0789
  • A0794
  • A0795
  • A0803
  • A0804
  • A0827
  • A0828
  • A0833
  • A0834

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

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