This device is not approved in the United States. Medtronic Concerto, C174AWK. Dual Chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular therapies. Medtronic, Inc., Minneapolis, MN 55432 USA.
This recall has been terminated (originally issued November 9, 2009).
- Recall Initiated
- September 9, 2009
- Posted
- November 9, 2009
- Terminated
- May 29, 2012
- Recall Number
- Z-0127-2010
- Quantity
- 267
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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
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, Netherlands, Norway, Portugal, Saudi Arabi, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Lot / Code Info
serial numbers: PVU600353S, PVU600444S, PVU600455S, PVU600466S, PVU600476S, PVU600478S, PVU600494S, PVU600497S, PVU600502S, PVU600505S, PVU600506S, PVU600507S, PVU600508S, PVU600512S, PVU600516S, PVU600518S, PVU600520S, PVU600522S, PVU600526S, PVU600529S, PVU600531S, PVU600534S, PVU600535S, PVU600536S, PVU600539S, PVU600543S, PVU600549S, PVU600558S, PVU600561S, PVU600568S, PVU600571S, PVU600573S, PVU600574S, PVU600582S, PVU600585S, PVU600595S, PVU600597S, PVU600598S, PVU600605S, PVU600607S, PVU600612S, PVU600617S, PVU600618S, PVU600619S, PVU600621S, PVU600622S, PVU600627S, PVU600631S, PVU600638S, PVU600640S, PVU600641S, PVU600646S, PVU600648S, PVU600652S, PVU600660S, PVU600664S, PVU600665S, PVU600675S, PVU600679S, PVU600680S, PVU600681S, PVU600682S, PVU600683S, PVU600685S, PVU600692S, PVU600694S, PVU600695S, PVU600698S, PVU600699S, PVU600703S, PVU600706S, PVU600708S, PVU600709S, PVU600711S, PVU600713S, PVU600718S, PVU600719S, PVU600721S, PVU600722S, PVU600723S, PVU600729S, PVU600767S, PVU600768S, PVU600781S, PVU600800S, PVU600806S, PVU600807S, PVU600808S, PVU600816S, PVU600819S, PVU600823S, PVU600825S, PVU600833S, PVU600834S, PVU600837S, PVU600840S, PVU600892S, PVU600898S, PVU600917S, PVU600949S, PVU600951S, PVU600957S, PVU600961S, PVU601001S, PVU601011S, PVU601012S, PVU601015S, PVU601020S, PVU601034S, PVU601035S, PVU601044S, PVU601052S, PVU601054S, PVU601058S, PVU601085S, PVU601108S, PVU601110S, PVU601115S, PVU601117S, PVU601120S, PVU601124S, PVU601133S, PVU601136S, PVU601140S, PVU601141S, PVU601142S, PVU601146S, PVU601147S, PVU601151S, PVU601153S, PVU601154S, PVU601159S, PVU601160S, PVU601162S, PVU601163S, PVU601164S, PVU601168S, PVU601170S, PVU601171S, PVU601177S, PVU601183S, PVU601190S, PVU601195S, PVU601197S, PVU601210S, PVU601211S, PVU601214S, PVU601219S, PVU601228S, PVU601231S, PVU601233S, PVU601234S, PVU601241S, PVU601243S, PVU601249S, PVU601256S, PVU601257S, PVU601258S, PVU601263S, PVU601269S, PVU601270S, PVU601274S, PVU601276S, PVU601282S, PVU601284S, PVU601285S, PVU601287S, PVU601289S, PVU601293S, PVU601301S, PVU601304S, PVU601314S, PVU601317S, PVU601320S, PVU601322S, PVU601325S, PVU601326S, PVU601329S, PVU601333S, PVU601341S, PVU601342S, PVU601343S, PVU601345S, PVU601350S, PVU601351S, PVU601354S, PVU601366S, PVU601368S, PVU601381S, PVU601398S, PVU601405S, PVU601410S, PVU601413S, PVU601430S, PVU601432S, PVU601433S, PVU601437S, PVU601456S, PVU601495S, PVU601499S, PVU601505S, PVU601519S, PVU601520S, PVU601521S, PVU601523S, PVU601524S, PVU601528S, PVU601532S, PVU601533S, PVU601548S, PVU601551S, PVU601555S, PVU601573S, PVU601577S, PVU601578S, PVU601581S, PVU601582S, PVU601585S, PVU601586S, PVU601592S, PVU601593S, PVU601604S, PVU601607S, PVU601611S, PVU601612S, PVU601614S, PVU601620S, PVU601623S, PVU601625S, PVU601635S, PVU601642S, PVU601651S, PVU601677S, PVU601686S, PVU601688S, PVU601694S, PVU601718S, PVU601719S, PVU601721S, PVU601723S, PVU601836S, PVU613075S, PVU613083S, PVU613107S, PVU613111S, PVU613112S, PVU613119S, PVU613123S, PVU613125S, PVU613127S, PVU613128S, PVU613129S, PVU613139S, PVU613141S, PVU613144S, PVU613151S, PVU613152S, PVU613153S, PVU613159S, PVU613170S, PVU613171S, PVU613177S, PVU613178S, PVU613187S, PVU613200S, PVU613206S, PVU613237S.
Root Cause
Nonconforming Material/Component
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.