Z-0127-2010

This device is not approved in the United States. Medtronic Concerto, C174AWK. Dual Chamber implantable...

Name: Z-0127-2010 This device is not approved in the United States. Medtronic Concerto, C174AWK. Dual Chamber implantable...
Creator: Medtronic Inc. Cardiac Rhythm Disease Managment
Published: 2009-09-09
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-09-09 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. Cardiac Rhythm Disease Managment began a recall of This device is not approved in the United States. Medtronic Concerto, C174AWK. Dual Chamber implantable cardioverter defibrillator with cardiac... on 2009-09-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0127-2010
Status: Terminated
Initiated: 2009-09-09
Posted: 2009-11-09
Terminated: 2012-05-29
Recalling firm: Medtronic, Inc.
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.
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
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
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code NIK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)