CONTAK RENEWAL 2 (model H155) Heart Failure Device. Sterilized with gaseous ethylene oxide. Guidant corporation, Cardiac

FDA device recall Z-0908-05 · posted 2005-06-30 · Terminated

Recall details

Recalling firm

Guidant Corporation

Reason for recall

Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.

Action taken

Dear Doctor letter was dated and issued 06/17/05 informing Doctors of an shorting issue of the Renewal 1 & 2 CRT-D devices. The letter gave indications of device failure and recommendations for patient visits. A press release was also issued on 06/17/05.

Root cause

Other

Status

Terminated

Product code

NIK

Quantity affected

16,000 (Approximately 11,900 remain implanted worldwide) - both products combined

Distribution

worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Czechoslovakia, Denmark, Finland, France,

Date initiated

2005-06-17

Date posted

2005-06-30

Date terminated

2007-01-10

Location

Saint Paul, MN