FDA WARNING_LETTER - Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc. - November 18, 2009

On May 17, 2010, the FDA issued a Warning Letter to HealthTronics, Inc., following an inspection of its wholly-owned subsidiary, Endocare, in Irvine, CA, from November 3 to November 18, 2009. The inspection revealed significant violations regarding cryosurgical units and accessories.

The devices, including Cryo-44-F V-Probe, PERC-24 Right Angle Probe, R2.4 Renal Probe, and CVA 2400 V-Probe, were deemed misbranded under 21 U.S.C. 352(t)(2) for failure to submit Medical Device Reports (MDRs) within 30 days for malfunctions likely to cause serious injury or death, as required by 21 CFR Part 803.50(a)(2). Specifically, unintended frosting during treatment, which could cause serious injury, was not reported.

Additionally, Fully Disposable Variable CryoProbe (V-Probe) devices were misbranded under 21 U.S.C. 352(t)(2) and 21 CFR Part 806 for failing to report a correction and removal within 10 working days. This correction involved design changes and customer communication to replace V-Probes due to a patient death attributed to air embolism.

Furthermore, significant design changes to V-Pro