Agency classClass IIOur severity:High FDA (Devices)·Z-2678-2020·Announced 2020-07-29

Boston Scientific Recalls IceFORCE Prostate Kit Due to Needle Surface Deterioration

Boston Scientific is recalling 79 IceFORCE 2.1 CX Prostate Kits because needle surfaces 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 a structural defect (needle surface deterioration) in a surgical device, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 79 units of the Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System. The recall involves Galil Medicals 2.1 CX Cryoablation Needles, which are prescription-only devices intended for the cryoablative destruction of tissue during surgical procedures.

The recall was initiated because the needle surface deteriorated due to unexpected electrolysis during the procedure. The affected devices were distributed nationwide to 40 states and the District of Columbia, as well as to Canada. Specific batch codes associated with the recall include A1105, A1193, A1291, A1435, A1550, A1565, A1776, A1781, A6758, A6930, A7062, A7061, and T0153.

Healthcare providers and patients who have used or possess these devices should contact Boston Scientific Corporation for further instructions on how to proceed. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product: Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, 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: structural-defect
device-deterioration
Affected units: 79

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 (15)

UPN: FPRPR3605
GTIN: 7290104831034
Batch: A1105
A1193
A1291
A1435
A1550
A1565
A1776
A1781
A6758
A6930
A7062
A7061
T0153

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 →

Same manufacturer · Boston Scientific Corporation

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Same hazard · structural defect