Z-0685-2021Class II

Three IcePearl" 2.1 CX Prostate Cryoablation Kit

Name: Z-0685-2021 Three IcePearl" 2.1 CX Prostate Cryoablation Kit
Creator: Boston Scientific Corporation
Published: 2020-11-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-11-18 / Completed

FDA source

Boston Scientific Corporation began a recall of Three IcePearl" 2.1 CX Prostate Cryoablation Kit on 2020-11-18. FDA classified it as Class II and gives the reason as "Complaint trend regarding needle shaft gas leaks". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0685-2021
Classification: Class II
Status: Completed
Initiated: 2020-11-18
Posted: 2020-12-22
Recalling firm: Boston Scientific Corporation
Product: Three IcePearl" 2.1 CX Prostate Cryoablation Kit
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: Complaint trend regarding needle shaft gas leaks.
FDA root cause: Under Investigation by firm
Action: Customers will be sent a product advisory via overnight mail.
Quantity in commerce: 117 units
Distribution: Nationwide
Product codes and lots: UPN: FPRPR3608 UDIs: 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065 Batch Numbers: U1308, U1304, U1066, U1034, U0859, U0860, U0661, U0660, U0609, U0588, T0815, T0816, T0270, T0238, T0212, T0211, T0181, T0144, T0055, A7122, A7027, A7014, A6926, A6913, A6900, A6857, A6744, A6710, A1937, A1583, A1461

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0685-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0657-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0658-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0659-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0660-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0661-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0662-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0663-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0664-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0665-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0666-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0667-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0668-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0669-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0670-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0671-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0672-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0673-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0674-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0675-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0676-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0677-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0678-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0679-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0680-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0681-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0682-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0683-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0684-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0685-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0686-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0687-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0688-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0689-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0690-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0691-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0692-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0693-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-30	2020-12-22

Product code GEH

K152133Class IIIcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE SystemGalil Medical , Ltd. / cleared 2015-08-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)