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Terminated

CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and CONTAK RENEWAL 4 HE CRT-D (model no. H197 and H199). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 5511-5798 USA. CONTAK RENEWAL 4 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.

FDA Recall Z-0950-05 · Posted 2005-06-30

Recalling FirmGuidant Corporation
Recall StatusTerminated
Product CodeNIK
Date Initiated2005-06-24
Date Terminated2006-12-31
Product Quantity7,490

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.

Firm Action

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

Distribution Pattern

worldwide. Including United States, Virgin Islands and countries such as Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Cyprus, Czech Republic, Denmark, Eygpt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Labanon, Luxembourg, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom and Venezuela.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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