Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias.
FDA Recall Z-1953-2009 · Posted 2009-08-18
Advertisement
Recalling FirmMedtronic Inc. Cardiac Rhythm Managment
Recall StatusTerminated
Product CodeLWS
Date Initiated2009-07-27
Date Terminated2012-05-31
Product Quantity1
Reason for Recall
Medtronic has detected a specific pattern of MOSFET IC malfunctions in its Concerto, Virtuoso and EnRhythm family of devices. The probability of occurrence decreases with time and, to date over 90% of the malfunctions related to the pattern have occurred within the first twelve months after implant.
Firm Action
Medtronic, Inc. personnel retrieved 2 non-implanted devices remaining at 2 hospitals. A Performance Notes letter was left at each facility. The Performance Notes described the issue, actions to address issue and recommendations to physicians. The Performance Notes will also be posted on the firm's website. Direct questions about this recall to Medtronic, Inc. by calling 1-763-514-4000.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution-- (states of IA and NJ).
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement