Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. Medtr

FDA device recall Z-1954-2009 · posted 2009-08-18 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Managment

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.

Action taken

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

Status

Terminated

Product code

LWS

Quantity affected

1

Distribution

Nationwide Distribution-- (states of IA and NJ).

Date initiated

2009-07-27

Date posted

2009-08-18

Date terminated

2012-05-31

Location

Mounds View, MN