Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricualar tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with suden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. The device also uses accelerometer-based adaptive-rate bradycardia therapy. These CONTAK RENEWAL RF devices feature enhanced telemetry communication with wandless ZIP telemetry. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

FDA Recall Z-0863-06 · Posted 2006-05-16

Recalling FirmGuidant Corporation
Recall StatusTerminated
Product CodeNIK
Date Initiated2006-03-11
Date Terminated2006-12-31
Product Quantity8,879

Reason for Recall

Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted.

Firm Action

Affected physicians were sent an Urgent Medical Device Safety Information & Corrective Action letter, dated 05/11/06. A press release was issued March 13, 2006 The letter describes the issue and emphasizes the importance of checking battery voltage prior to implant as stated in device labeling. For implanted devices, continue normal follow-up.

Root Cause

Other

Distribution Pattern

Nationwide, Puerto Rico, Virgin Islands and to countries that include: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iran, Ireland, Israel, Italy, Luxembourg, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom

Official Source

View FDA Recall →

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

↑