Agency classClass IIOur severity:High FDA (Devices)·Z-0689-2021·Announced 2020-12-30

Boston Scientific Recalls Five IceSphere Prostate Cryoablation Kits Due to Gas Leaks

Boston Scientific is recalling 419 Five IceSphere Prostate Cryoablation Kits nationwide due to 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, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard involves a functional defect (gas leak) in a medical device used for an invasive procedure, posing a risk of harm without reported fatalities or permanent injury.

Plain-English summary

Boston Scientific Corporation is recalling 419 units of the Five IceSphere Prostate Cryoablation Kit. The recall is being conducted due to a complaint trend regarding needle shaft gas leaks. The affected products were distributed nationwide.

The recall involves specific units identified by UPN FPRPR3570 and various batch numbers, including U1402, U1223, U1224, U1225, U1177, U1178, U1118, U1115, U1070, U1069, U0824, U0825, U0823, U0826, U0470, U0411, U0402, U0407, U0384, U0389, U0216, U0183, U0122, U0154, U0155, T0673, T0672, T0635, T0484, T0483, T0461, T0462, T0373, T0374, T0363, T0362, T0127, T0104, T0103, A7009, A6953, A6952, A6890, A6789, A6737, A2101, A2088, A1629, A1626, A1607, A1577, A1382, and A1184. The agency has classified this as a Class II recall.

Healthcare providers and patients should check their inventory and patient records for these specific batch numbers. If a patient has received one of these kits, they should contact their healthcare provider or Boston Scientific for further instructions on the recall and potential replacement or refund.

The recalled product

Product: Five IceSphere" Prostate Cryoablation Kit
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Urological / Cryoablation
Hazard: gas-leak
device-malfunction
Affected units: 419

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: FPRPR3570 UDIs: 7290104830969
7290104830969
7290104830969 Batch Numbers: U1402
U1223
U1224
U1225
U1177
U1178
U1118
U1115
U1070
U1069
U0824
U0825
U0823
U0826
U0470
U0411
U0402
U0407

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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Same hazard · gas leak