Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators

Hazard

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Details from the source

Reason for recall: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds. Distribution: US Nationwide - Worldwide Distribution Quantity: 14989 units Lot/code info: GTIN 00763000001629, Lot Serial Numbers: CWR601226S, CWR601747S, CWR614516S, CWR615056S, CWR611693S, CWR610177S, CWR613808S, CWR600732S, CWR606430S, CWR602651S, CWR607356S, CWR610310S, CWR604045S, CWR603303S, CWR609623S, CWR605872S, CWR601687S, CWR603211S, CWR602807S, CWR607694S, CWR613692S, CWR613696S, CWR605094S, CWR610428S, CWR606832S, CWR607019S, CWR612869S, CWR614166S, CWR614552S, CWR608782S, CWR611713S, CWR614839S, CWR613888S, CWR614119S, CWR614102S, CWR614110S, CWR613089S, CWR612399S, CWR608766S, CWR614937S, CWR612224S, CWR614130S, CWR612786S, CWR614153S, CWR613324S, CWR612299S, CWR612283S, CWR612754S, CWR610251S, CWR610659S, CWR604739S, CWR605422S, CWR605753S, CWR606253S, CWR607872S, CWR609650S, CWR613342S, CWR606875S, CWR601224S, CWR601549S, CWR601550S, CWR602194S, CWR603281S, CWR603711S, CWR604836S, CWR605024S, CWR605378S, CWR606857S, CWR609093S, CWR600564S, CWR601374S, CWR601412S, CWR602016S, CWR602048S, CWR602172S, CWR602215S, CWR602229S, CWR602850S, CWR604727S, CWR604841S, CWR605233S, CWR605740S, CWR606077S, CWR606621S, CWR607419S, CWR607905S, CWR609837S, CWR609987S, CWR610588S, CWR611070S, CWR611189S, CWR611604S, CWR611683S, CWR613086S, CWR614108S, CWR614126S, CWR614582S, CWR600290S, CWR600798S, CWR600903S, CWR601809S, CWR601823S, CWR602693S, CWR600201S, CWR600280S, CWR600780S, CWR601028S, CWR601781S, CWR602187S, CWR602514S, CWR602565S, CWR602736S, CWR602986S, CWR603209S, CWR605149S, CWR605488S, CWR605758S, CWR605886S, CWR606853S, CWR608265S, CWR609492S, CWR6101

UPC codes

00763000001629

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.