Z-1953-2009

Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and...

Name: Z-1953-2009 Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and...
Creator: Medtronic Inc. Cardiac Rhythm Managment
Published: 2009-07-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-07-27 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. Cardiac Rhythm Managment began a recall of Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. Medtronic, Inc., 710 Medtronic... on 2009-07-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1953-2009
Status: Terminated
Initiated: 2009-07-27
Posted: 2009-08-18
Terminated: 2012-05-31
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 1
Distribution: Nationwide Distribution-- (states of IA and NJ).
Product codes and lots: Serial number: PUL450634H.

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)