CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and CONTAK RENEWAL 4 HE CRT-D (model no. H197 and H199). Cardiac Resync

FDA device recall Z-0950-05 · posted 2005-06-30 · Terminated

Recall details

Recalling firm

Guidant Corporation

Reason for recall

Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.

Action taken

Firm issued a Dr. Doctor letter dated 06/23/05. Letter informs physicians of the issue, clinical implications and recommendations. UPDATE: An Advisory Update, dated 08/01/05 is being issued to physicians to inform them of a new programmer software application upgrade and the programmer screen alerts. Additionally regulatory approval was given for a new switch component that will be incorporated into all Guidant CRT-D products.

Root cause

Other

Status

Terminated

Product code

NIK

Quantity affected

7,490

Distribution

worldwide. Including United States, Virgin Islands and countries such as Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Cyprus, Czech Republic, Den

Date initiated

2005-06-24

Date posted

2005-06-30

Date terminated

2006-12-31

Location

Saint Paul, MN