Recall Z-1401-2010 ยท GEH Unit, Cryosurgical, Accessories
Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.
V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. 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.
| Date | Apr 16, 2010 (initiated Dec 5, 2008) |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 22,741 units total for all products |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |