Agency classClass IIOur severity:High FDA (Devices)·Z-2680-2020·Announced 2020-07-29

Boston Scientific Recalls Prostate Cryoablation Kits Due to Needle Deterioration

Boston Scientific is recalling 88 Prostate Cryoablation Kits because needle surfaces deteriorated during procedures due to unexpected electrolysis.

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, and the source describes a physical defect (needle surface deterioration) in a surgical device without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 88 units of the Ablation Galil Technology Three IceFORCE 2.1 CX Prostate Cryoablation Kit Visual ICE System. The recall involves specific batches of 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 44 states and the District of Columbia, as well as to Canada.

Healthcare providers and patients who have used or may have used these specific devices should contact Boston Scientific Corporation for further instructions on how to proceed. The recall number is Z-2680-2020.

The recalled product

Product: Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation 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: device-defect
electrolysis
Affected units: 88

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 (17)

UPN:FPRPR3607
GTIN: 7290104831058
Batch: A1194
A1298
A1436
A1569
A1567
A1782
A6754
A6757
A6848
A6849
A6915
T0154
T0163
T0552
U0083

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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