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

FDA device recall Z-0129-2010 · posted 2009-11-09 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Managment

Reason for recall

A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionalit

Action taken

An "Important Medical Device Information" letter, dated September 2009 was hand delivered by Medtronic Representatives beginning 09/09/09. The letter describes the issue, identifies affected devices and provides recommendations for patients with devices in the affected subset.. A Patient letter was mailed to patients beginning 09/28/09. For additional information: Doctors are advised to contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636; Device tracking managers are advised to contact your Medtronic representative, or the Patient Registration Department at 1-800-328-2518 x41832; and Patients are advised to contact Medtronic Patient Services number at 800-551-5544 ext. 41835.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LWS

Quantity affected

10

Distribution

Worldwide distribution (except Idaho and Wyoming) including countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait

Date initiated

2009-09-09

Date posted

2009-11-09

Date terminated

2012-05-29

Location

Saint Paul, MN