V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. The product is used in a minimally invasive, percutaneous a

FDA device recall Z-1401-2010 · posted 2010-04-16 · Terminated

Recall details

Recalling firm

Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

GEH

Quantity affected

22,741 units total for all products

Distribution

Nationwide.

Date initiated

2008-12-05

Date posted

2010-04-16

Date terminated

2010-10-21

Location

Irvine, CA

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