Medtronic Inc. Cardiac Rhythm Disease Managment This device is not approved in the United States. Medtronic Virtuoso DR, D164AWG. Medtronic, Inc., Minneapolis, MN 55432 USA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
This device is not approved in the United States. Medtronic Virtuoso DR, D164AWG. Medtronic, Inc., Minneapolis, MN 55432 USA.
Brand
Medtronic Inc. Cardiac Rhythm Disease Managment
Lot Codes / Batch Numbers
serial numbers: PVV600002S, PVV600003S, PVV600005S, PVV600008S, PVV600009S, PVV600010S, PVV600011S, PVV600013S, PVV600015S, PVV600016S, PVV600017S, PVV600018S, PVV600019S, PVV600020S, PVV600022S, PVV600023S, PVV600027S, PVV600028S, PVV600029S, PVV600030S, PVV600031S, PVV600033S, PVV600035S, PVV600036S, PVV600038S, PVV600040S, PVV600041S, PVV600043S, PVV600044S, PVV600045S, PVV600046S, PVV600047S, PVV600048S, PVV600049S, PVV600050S, PVV600054S, PVV600055S, PVV600056S, PVV600057S, PVV600058S, PVV600059S, PVV600060S, PVV600061S, PVV600062S, PVV600063S, PVV600064S, PVV600065S, PVV600066S, PVV600067S, PVV600069S, PVV600070S, PVV600071S, PVV600072S, PVV600073S, PVV600075S, PVV600076S, PVV600078S, PVV600079S, PVV600080S, PVV600082S, PVV600083S, PVV600084S, PVV600087S, PVV600088S, PVV600089S, PVV600090S, PVV600091S, PVV600092S, PVV600093S, PVV600094S, PVV600096S, PVV600097S, PVV600098S, PVV600100S, PVV600102S, PVV600103S, PVV600104S, PVV600105S, PVV600106S, PVV600107S, PVV600108S, PVV600109S, PVV600110S, PVV600111S, PVV600112S, PVV600114S, PVV600115S, PVV600116S, PVV600117S, PVV600118S, PVV600119S, PVV600120S, PVV600122S, PVV600124S, PVV600125S, PVV600126S, PVV600128S, PVV600129S, PVV600130S, PVV600131S, PVV600133S, PVV600134S, PVV600137S, PVV600138S, PVV600139S, PVV600140S, PVV600141S, PVV600142S, PVV600143S, PVV600144S, PVV600146S, PVV600147S, PVV600148S, PVV600149S, PVV600150S, PVV600151S, PVV600153S, PVV600154S, PVV600156S, PVV600157S, PVV600158S, PVV600159S, PVV600161S, PVV600162S, PVV600163S, PVV600164S, PVV600180S, PVV600184S, PVV600185S, PVV600188S, PVV600195S, PVV600199S, PVV600202S, PVV600203S, PVV600207S, PVV600214S, PVV600215S, PVV600216S, PVV600217S, PVV600218S, PVV600219S, PVV600221S, PVV600222S, PVV600223S, PVV600224S, PVV600226S, PVV600227S, PVV600228S, PVV600230S, PVV600232S, PVV600233S, PVV600234S, PVV600235S, PVV600236S, PVV600237S, PVV600238S, PVV600246S, PVV600251S, PVV600263S, PVV600265S, PVV600267S, PVV600268S, PVV600270S, PVV600272S, PVV600273S, PVV600281S, PVV600284S, PVV600288S, PVV600296S, PVV600302S, PVV600303S, PVV600315S, PVV600322S, PVV600331S, PVV600332S, PVV600334S, PVV600337S, PVV600339S, PVV600349S, PVV600350S, PVV600351S, PVV600352S, PVV600354S, PVV600355S, PVV600356S, PVV600359S, PVV600360S, PVV600363S, PVV600364S, PVV600379S, PVV600380S, PVV600383S, PVV600392S, PVV600394S, PVV600397S, PVV600400S, PVV600405S, PVV600408S, PVV600410S, PVV600414S, PVV600419S, PVV600420S, PVV600433S, PVV600437S, PVV600439S, PVV600442S, PVV600445S, PVV600446S, PVV600448S, PVV600450S, PVV600452S, PVV600453S, PVV600458S, PVV600461S, PVV600464S, PVV600465S, PVV600467S, PVV600471S, PVV600479S, PVV600485S, PVV600491S, PVV600495S, PVV600501S, PVV600503S, PVV600504S, PVV600505S, PVV600507S, PVV600508S, PVV600512S, PVV600516S, PVV600518S, PVV600521S, PVV600526S, PVV600527S, PVV600530S, PVV600535S, PVV600548S, PVV600554S, PVV600557S, PVV600560S, PVV600567S, PVV600572S, PVV600578S, PVV600579S, PVV600583S, PVV600585S, PVV600587S, PVV600588S, PVV600591S, PVV600597S, PVV600600S, PVV600603S, PVV600605S, PVV600606S, PVV600612S, PVV600613S, PVV600614S, PVV600615S, PVV600616S, PVV600617S, PVV600623S, PVV600624S, PVV600635S, PVV600641S, PVV600642S, PVV600643S, PVV600646S, PVV600647S, PVV600649S, PVV600651S, PVV600656S, PVV600660S, PVV600661S, PVV600669S, PVV600670S, PVV600675S, PVV600679S, PVV600681S, PVV600693S, PVV600694S, PVV600707S, PVV600709S, PVV600710S, PVV600718S, PVV600722S, PVV600724S, PVV600727S, PVV600729S, PVV600730S, PVV600732S, PVV600733S, PVV600740S, PVV600742S, PVV600751S, PVV600768S, PVV600786S, PVV600787S, PVV600793S, PVV600795S, PVV600803S, PVV600810S, PVV600820S, PVV600824S, PVV600842S, PVV600846S, PVV600850S, PVV600855S, PVV600863S, PVV600871S, PVV600874S, PVV600875S, PVV600880S, PVV600881S, PVV600888S, PVV600896S, PVV600898S, PVV600899S, PVV600900S, PVV600901S, PVV600902S, PVV600903S, PVV600904S, PVV600905S, PVV600906S, PVV600907S, PVV600909S, PVV600910S, PVV600912S, PVV600913S, PVV600914S, PVV600915S, PVV600916S, PVV600918S, PVV600919S, PVV600920S, PVV600922S, PVV600923S, PVV600924S, PVV600925S, PVV600926S, PVV600927S, PVV600928S, PVV600930S, PVV600932S, PVV600933S, PVV600936S, PVV600940S, PVV600941S, PVV600944S, PVV600946S, PVV600951S, PVV600954S, PVV600960S, PVV600961S, PVV600963S, PVV600965S, PVV600970S, PVV600976S, PVV600981S, PVV600984S, PVV600986S, PVV600990S, PVV600993S, PVV600995S, PVV600999S, PVV601005S, PVV601016S, PVV601027S, PVV601034S, PVV601086S, PVV601089S, PVV601092S, PVV601097S, PVV601102S, PVV601111S, PVV601112S, PVV601113S, PVV601130S, PVV601132S, PVV601134S, PVV601136S, PVV601141S, PVV601147S, PVV601150S, PVV601151S, PVV601156S, PVV601159S, PVV601163S, PVV601169S, PVV601174S, PVV601175S, PVV601181S, PVV601196S, PVV601202S, PVV601204S, PVV601222S, PVV601223S, PVV601224S, PVV601225S, PVV601226S, PVV601227S, PVV601228S, PVV601229S, PVV601230S, PVV601231S, PVV601232S, PVV601233S, PVV601234S, PVV601235S, PVV601236S, PVV601239S, PVV601242S, PVV601243S, PVV601244S, PVV601245S, PVV601252S, PVV601256S, PVV601286S, PVV601292S, PVV601343S, PVV601344S, PVV601350S, PVV601355S, PVV601358S, PVV601362S, PVV603655S, PVV603658S, PVV603660S, PVV603670S.
Products Sold
serial numbers: PVV600002S, PVV600003S, PVV600005S, PVV600008S, PVV600009S, PVV600010S, PVV600011S, PVV600013S, PVV600015S, PVV600016S, PVV600017S, PVV600018S, PVV600019S, PVV600020S, PVV600022S, PVV600023S, PVV600027S, PVV600028S, PVV600029S, PVV600030S, PVV600031S, PVV600033S, PVV600035S, PVV600036S, PVV600038S, PVV600040S, PVV600041S, PVV600043S, PVV600044S, PVV600045S, PVV600046S, PVV600047S, PVV600048S, PVV600049S, PVV600050S, PVV600054S, PVV600055S, PVV600056S, PVV600057S, PVV600058S, PVV600059S, PVV600060S, PVV600061S, PVV600062S, PVV600063S, PVV600064S, PVV600065S, PVV600066S, PVV600067S, PVV600069S, PVV600070S, PVV600071S, PVV600072S, PVV600073S, PVV600075S, PVV600076S, PVV600078S, PVV600079S, PVV600080S, PVV600082S, PVV600083S, PVV600084S, PVV600087S, PVV600088S, PVV600089S, PVV600090S, PVV600091S, PVV600092S, PVV600093S, PVV600094S, PVV600096S, PVV600097S, PVV600098S, PVV600100S, PVV600102S, PVV600103S, PVV600104S, PVV600105S, PVV600106S, PVV600107S, PVV600108S, PVV600109S, PVV600110S, PVV600111S, PVV600112S, PVV600114S, PVV600115S, PVV600116S, PVV600117S, PVV600118S, PVV600119S, PVV600120S, PVV600122S, PVV600124S, PVV600125S, PVV600126S, PVV600128S, PVV600129S, PVV600130S, PVV600131S, PVV600133S, PVV600134S, PVV600137S, PVV600138S, PVV600139S, PVV600140S, PVV600141S, PVV600142S, PVV600143S, PVV600144S, PVV600146S, PVV600147S, PVV600148S, PVV600149S, PVV600150S, PVV600151S, PVV600153S, PVV600154S, PVV600156S, PVV600157S, PVV600158S, PVV600159S, PVV600161S, PVV600162S, PVV600163S, PVV600164S, PVV600180S, PVV600184S, PVV600185S, PVV600188S, PVV600195S, PVV600199S, PVV600202S, PVV600203S, PVV600207S, PVV600214S, PVV600215S, PVV600216S, PVV600217S, PVV600218S, PVV600219S, PVV600221S, PVV600222S, PVV600223S, PVV600224S, PVV600226S, PVV600227S, PVV600228S, PVV600230S, PVV600232S, PVV600233S, PVV600234S, PVV600235S, PVV600236S, PVV600237S, PVV600238S, PVV600246S, PVV600251S, PVV600263S, PVV600265S, PVV600267S, PVV600268S, PVV600270S, PVV600272S, PVV600273S, PVV600281S, PVV600284S, PVV600288S, PVV600296S, PVV600302S, PVV600303S, PVV600315S, PVV600322S, PVV600331S, PVV600332S, PVV600334S, PVV600337S, PVV600339S, PVV600349S, PVV600350S, PVV600351S, PVV600352S, PVV600354S, PVV600355S, PVV600356S, PVV600359S, PVV600360S, PVV600363S, PVV600364S, PVV600379S, PVV600380S, PVV600383S, PVV600392S, PVV600394S, PVV600397S, PVV600400S, PVV600405S, PVV600408S, PVV600410S, PVV600414S, PVV600419S, PVV600420S, PVV600433S, PVV600437S, PVV600439S, PVV600442S, PVV600445S, PVV600446S, PVV600448S, PVV600450S, PVV600452S, PVV600453S, PVV600458S, PVV600461S, PVV600464S, PVV600465S, PVV600467S, PVV600471S, PVV600479S, PVV600485S, PVV600491S, PVV600495S, PVV600501S, PVV600503S, PVV600504S, PVV600505S, PVV600507S, PVV600508S, PVV600512S, PVV600516S, PVV600518S, PVV600521S, PVV600526S, PVV600527S, PVV600530S, PVV600535S, PVV600548S, PVV600554S, PVV600557S, PVV600560S, PVV600567S, PVV600572S, PVV600578S, PVV600579S, PVV600583S, PVV600585S, PVV600587S, PVV600588S, PVV600591S, PVV600597S, PVV600600S, PVV600603S, PVV600605S, PVV600606S, PVV600612S, PVV600613S, PVV600614S, PVV600615S, PVV600616S, PVV600617S, PVV600623S, PVV600624S, PVV600635S, PVV600641S, PVV600642S, PVV600643S, PVV600646S, PVV600647S, PVV600649S, PVV600651S, PVV600656S, PVV600660S, PVV600661S, PVV600669S, PVV600670S, PVV600675S, PVV600679S, PVV600681S, PVV600693S, PVV600694S, PVV600707S, PVV600709S, PVV600710S, PVV600718S, PVV600722S, PVV600724S, PVV600727S, PVV600729S, PVV600730S, PVV600732S, PVV600733S, PVV600740S, PVV600742S, PVV600751S, PVV600768S, PVV600786S, PVV600787S, PVV600793S, PVV600795S, PVV600803S, PVV600810S, PVV600820S, PVV600824S, PVV600842S, PVV600846S, PVV600850S, PVV600855S, PVV600863S, PVV600871S, PVV600874S, PVV600875S, PVV600880S, PVV600881S, PVV600888S, PVV600896S, PVV600898S, PVV600899S, PVV600900S, PVV600901S, PVV600902S, PVV600903S, PVV600904S, PVV600905S, PVV600906S, PVV600907S, PVV600909S, PVV600910S, PVV600912S, PVV600913S, PVV600914S, PVV600915S, PVV600916S, PVV600918S, PVV600919S, PVV600920S, PVV600922S, PVV600923S, PVV600924S, PVV600925S, PVV600926S, PVV600927S, PVV600928S, PVV600930S, PVV600932S, PVV600933S, PVV600936S, PVV600940S, PVV600941S, PVV600944S, PVV600946S, PVV600951S, PVV600954S, PVV600960S, PVV600961S, PVV600963S, PVV600965S, PVV600970S, PVV600976S, PVV600981S, PVV600984S, PVV600986S, PVV600990S, PVV600993S, PVV600995S, PVV600999S, PVV601005S, PVV601016S, PVV601027S, PVV601034S, PVV601086S, PVV601089S, PVV601092S, PVV601097S, PVV601102S, PVV601111S, PVV601112S, PVV601113S, PVV601130S, PVV601132S, PVV601134S, PVV601136S, PVV601141S, PVV601147S, PVV601150S, PVV601151S, PVV601156S, PVV601159S, PVV601163S, PVV601169S, PVV601174S, PVV601175S, PVV601181S, PVV601196S, PVV601202S, PVV601204S, PVV601222S, PVV601223S, PVV601224S, PVV601225S, PVV601226S, PVV601227S, PVV601228S, PVV601229S, PVV601230S, PVV601231S, PVV601232S, PVV601233S, PVV601234S, PVV601235S, PVV601236S, PVV601239S, PVV601242S, PVV601243S, PVV601244S, PVV601245S, PVV601252S, PVV601256S, PVV601286S, PVV601292S, PVV601343S, PVV601344S, PVV601350S, PVV601355S, PVV601358S, PVV601362S, PVV603655S, PVV603658S, PVV603660S, PVV603670S.
Medtronic Inc. Cardiac Rhythm Disease Managment is recalling This device is not approved in the United States. Medtronic Virtuoso DR, D164AWG. Medtronic, Inc., due to 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 grad. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
ID, WY
Page updated: Jan 10, 2026