Z-1400-2010

V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invasive, percutaneous...

Name: Z-1400-2010 V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invasive, percutaneous...
Creator: Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.
Published: 2008-12-05
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2008-12-05 / Terminated

FDA source

Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc. began a recall of V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low... on 2008-12-05. The reason FDA records is "Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1400-2010
Status: Terminated
Initiated: 2008-12-05
Posted: 2010-04-16
Terminated: 2010-10-21
Recalling firm: Varian Medical Systems, Inc.
Product: V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on the Indications and Safety Review included with the Physician Training Materials and to reinforce additional safety information.
FDA root cause: Other
Action: The recall was initiated with Endocare sending a notification letter to identified customers on December 5, 2008 and offering an optional replacement unit. The initial correspondence was sent out via an e-mail if the correspondence was returned undeliverable or an e-mail address was not available it was then sent Federal Express to those recipients. The notification letter explained the reason for recall and requested providers refocus their attention on the Indications & Safety Review information contained in the Endocare's Physician Training Materials. Physicians were instructed to contact the firm at 1-949-450-5412 to discuss any questions they may have about the information in the notification letter.
Quantity in commerce: 22,741 units total for all products
Distribution: Nationwide.
Product codes and lots: Lot Numbers 08-0522.

Product code GEH

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)