Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; 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: 11,645 units Lot/code info: GTIN 00763000178390, Lot Serial Numbers: RSO600207S, RSO600934S, RSO602587S, RSO602860S, RSO603892S, RSO600679S, RSO612257S, RSO602636S, RSO604992S, RSO609567S, RSO609647S, RSO609795S, RSO609900S, RSO610931S, RSO607136S, RSO609278S, RSO601095S, RSO601096S, RSO601098S, RSO601472S, RSO601473S, RSO601474S, RSO601475S, RSO601476S, RSO601477S, RSO601478S, RSO601479S, RSO604357S, RSO604358S, RSO605928S, RSO606135S, RSO606155S, RSO603632S, RSO603681S, RSO607412S, RSO607605S, RSO610650S, RSO600968S, RSO601258S, RSO603258S, RSO603300S, RSO603339S, RSO603742S, RSO603773S, RSO612385S, RSO601910S, RSO601911S, RSO601913S, RSO602604S, RSO602611S, RSO603824S, RSO603826S, RSO603876S, RSO609857S, RSO610204S, RSO609865S, RSO610317S, RSO601050S, RSO601392S, RSO601568S, RSO601741S, RSO604464S, RSO600230S, RSO610679S, RSO612158S, RSO612159S, RSO608401S, RSO608413S, RSO613154S, RSO613155S, RSO609928S, RSO610881S, RSO611808S, RSO600081S, RSO600082S, RSO600083S, RSO600951S, RSO600986S, RSO601604S, RSO604972S, RSO605522S, RSO606607S, RSO607741S, RSO606041S, RSO601440S, RSO605663S, RSO607178S, RSO607206S, RSO609698S, RSO603723S, RSO602519S, RSO603022S, RSO603027S, RSO603552S, RSO603805S, RSO603832S, RSO603833S, RSO604179S, RSO604194S, RSO604476S, RSO604477S, RSO604521S, RSO604971S, RSO604986S, RSO605288S, RSO605313S, RSO606154S, RSO606633S, RSO606984S, RSO607027S, RSO607059S, RSO607060S, RSO607066S, RSO607258S, RSO609917S, RSO601016S, RSO602843S, RSO603638S, RSO603828S, RSO603945S, RSO604008S, RSO6040

UPC codes

00763000178390

Source

Official record: FDA (Device enforcement) ↗

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