Medtronic Inc. Cardiac Rhythm Disease Managment: 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.

Recall number

Z-0127-2010

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Managment

Product

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.

Status

Terminated

Initiated

2009-09-09

Posted

2009-11-09

Terminated

2012-05-29

Reason

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

Root cause

Nonconforming Material/Component

Action

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.

Quantity

267

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, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

NIK

Firm FEI

2182208

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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