Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gas

FDA device recall Z-0906-05 · posted 2005-06-30 · Terminated

Recall details

Recalling firm

Guidant Corporation

Reason for recall

Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjuction with other factors, resulted in an electrical short. The short caused diversion of shock therapy energy away from the heart and into device circuitry.

Action taken

Dear Doctor letter, dated 05/23/05, was sent to doctors 05/23/05 making them aware of 26 random component failures including one death. Doctors were advised to continue normal monitoring of all patients as indicated in device labeling. Press Release was also issued 05/25/05. Another Dear Doctor letter was dated and issued on 06/17/05. This letter provided updated information to the 05/23/05 letter. The letter gave some indications of device failure and recommendations for normal patient monitoring on routine follow-up visits. Another press release was also issued on 06/17/05.

Root cause

Other

Status

Terminated

Product code

KRG

Quantity affected

38,362 (Approx. 24,000 are currently implanted worldwide)

Distribution

Worldwide. Including United States and countries such as: Arab Emirates, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechoslovakia, Denmark, Finland, France, Germ

Date initiated

2005-06-17

Date posted

2005-06-30

Date terminated

2007-01-05

Location

Saint Paul, MN