Agency classClass IIOur severity:High FDA (Devices)·Z-2683-2020·Announced 2020-07-29

Boston Scientific Recalls IceForce 2.1 CX Cryoablation Needles

Boston Scientific is recalling 656 IceForce 2.1 CX 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 device malfunction (surface deterioration) during a surgical procedure, which poses a risk of harm, but the source text does not report specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 656 units of the Ablation Galil Technology, IceForce 2.1 CX 90 Cryoablation Needles. These prescription-only medical devices are intended for the cryoablative destruction of tissue during surgical procedures.

The recall was initiated because the needle surface deteriorated due to unexpected electrolysis occurring during the procedure. The affected devices were distributed nationwide to numerous U.S. states and to Canada.

Healthcare providers and patients should stop using these specific devices. The recall includes specific batch numbers and product codes listed in the official FDA notice. Users should contact Boston Scientific or their supplier for further instructions on how to return or replace the affected needles.

The recalled product

Product: Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, 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 Instruments
Hazard: device-malfunction
electrolysis
Affected units: 656

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: FPRPR3618
GTIN: 07290104831089
Batch: X2073
X6812
A0815
A0994
A1044
A1046
A1188
A1189
A1544
A1545
A1774
A1775
A2029
A2030
A6677
A6678
A7032
A7033

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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