Three IceFORCE" 2.1 CX Prostate Cryoablation Kit recallZ-0684-2021 · Boston Scientific Corporation · initiated Nov 18, 2020

Completed

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Complaint trend regarding needle shaft gas leaks.

FDA root cause category: Under Investigation by firm

What the company is doing

Customers will be sent a product advisory via overnight mail.

Recall details

Recall number: Z-0684-2021
Status: Completed
Initiated by the company: Nov 18, 2020
Recalling firm: Boston Scientific Corporation
Quantity: 140 units
Product code: GEH
FDA submissions: K152133
Distribution: Nationwide

Product description

Three IceFORCE" 2.1 CX Prostate Cryoablation Kit

Code information (models, lots, serial numbers)

UPN: FPRPR3607 UDIs: 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058 Batch Numbers: U1302, U1303, U1301, U1032, U0616, U0590, U0589, U0583, U0540, U0363, U0318, U0083, T0552, T0163, T0154, A6915, A6849, A6848, A6757, A6754, A1782, A1569, A1567, A1436, A1298, A1194

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Three IceFORCE ® 2.1 CX Prostate Cryoablation Kit Visual-ICE® System FPRPR3607
Boston Scientific Corporation · Unit, Cryosurgical, Accessories
2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 86777).

Z-0657-2021 · Completed
IceFORCE" 2.1 CX 90 Cryoablation Needle
Z-0658-2021 · Completed
IceFORCE" 2.1 CX Cryoablation Needle
Z-0659-2021 · Completed
IceFORCE" 2.1 CX L 90 Cryoablation Needle
Z-0660-2021 · Completed
IcePearl" 2.1 CX 90 Cryoablation Needle
Z-0661-2021 · Completed
IcePearl" 2.1 CX Cryoablation Needle
Z-0662-2021 · Completed
IcePearl" 2.1 CX L 90 Cryoablation Needle
Z-0663-2021 · Completed
IceRod" 1.5 CX 90 Cryoablation Needle
Z-0664-2021 · Completed
IceSphere" 1.5 CX 90 Cryoablation Needle
Z-0665-2021 · Completed
IceRod" 1.5 i-Thaw" Cryoablation Needle
Z-0666-2021 · Completed
IceRod" 1.5 PLUS 90 Cryoablation Needle
Z-0667-2021 · Completed
IceRod" 1.5 PLUS Cryoablation Needle
Z-0668-2021 · Completed
IceRod" 1.5 90 Cryoablation Needle
Z-0669-2021 · Completed
IceRod" 1.5 Cryoablation Needle
Z-0670-2021 · Completed
IceSphere" 1.5 90 Cryoablation Needle
Z-0671-2021 · Completed
IceSphere" 1.5 Cryoablation Needle
Z-0672-2021 · Completed
IceSphere" 1.5 S 90 Cryoablation Needle
Z-0673-2021 · Completed
IceSphere" 1.5 90 Cryoablation Needle
Z-0674-2021 · Completed
IceSphere" 1.5 Cryoablation Needle
Z-0675-2021 · Completed
IceSeed" 1.5 90 Cryoablation Needle
Z-0676-2021 · Completed
IceSeed" 1.5 Cryoablation Needle
Z-0677-2021 · Completed
IceEDGE" 2.4 90p Cryoablation Needle
Z-0678-2021 · Completed
IceRod" 1.5 MRI 90 Cryoablation Needle
Z-0679-2021 · Completed
IceRod" 1.5 MRI Cryoablation Needle
Z-0680-2021 · Completed
IceSeed" 1.5 MRI 90 Cryoablation Needle
Z-0681-2021 · Completed
IceSeed" 1.5 MRI Cryoablation Needle
Z-0682-2021 · Completed
IceFORCE" 2.1 CX Prostate Cryoablation Kit
Z-0683-2021 · Completed
IcePearl" 2.1 CX Prostate Cryoablation Kit
Z-0685-2021 · Completed
Three IcePearl" 2.1 CX Prostate Cryoablation Kit
Z-0686-2021 · Completed
IceRod" i-Thaw" Prostate Cryoablation Kit
Z-0687-2021 · Completed
IceSeed" Prostate Cryoablation Kit

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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