Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; 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: 3801 units Lot/code info: GTIN 00763000001483, Lot Serial Numbers: CWM603134S, CWM600439S, CWM601269S, CWM603840S, CWM603922S, CWM601037S, CWM602990S, CWM603292S, CWM602888S, CWM602567S, CWM604350S, CWM604400S, CWM604147S, CWM604447S, CWM603919S, CWM604293S, CWM603993S, CWM604453S, CWM604276S, CWM603779S, CWM603512S, CWM604434S, CWM604110S, CWM603974S, CWM604303S, CWM604451S, CWM604296S, CWM603643S, CWM604349S, CWM603935S, CWM603697S, CWM603897S, CWM604404S, CWM603551S, CWM601796S, CWM601798S, CWM601800S, CWM601801S, CWM601802S, CWM601905S, CWM601911S, CWM601931S, CWM602000S, CWM602003S, CWM602004S, CWM602005S, CWM602006S, CWM602097S, CWM602098S, CWM602124S, CWM602139S, CWM602709S, CWM602710S, CWM602711S, CWM602823S, CWM602836S, CWM602838S, CWM602847S, CWM602848S, CWM602883S, CWM602898S, CWM603276S, CWM600958S, CWM601164S, CWM601353S, CWM601410S, CWM601640S, CWM601831S, CWM602141S, CWM603581S, CWM603582S, CWM603627S, CWM603628S, CWM604291S, CWM604292S, CWM601211S, CWM601263S, CWM601339S, CWM601506S, CWM601641S, CWM601775S, CWM601830S, CWM601834S, CWM601838S, CWM601839S, CWM601969S, CWM601974S, CWM601975S, CWM601982S, CWM602156S, CWM602313S, CWM602566S, CWM602573S, CWM602580S, CWM602662S, CWM602663S, CWM602864S, CWM602921S, CWM603097S, CWM603100S, CWM603191S, CWM603193S, CWM603334S, CWM603336S, CWM603361S, CWM603421S, CWM603445S, CWM603446S, CWM603573S, CWM603574S, CWM603714S, CWM603717S, CWM603718S, CWM603719S, CWM603720S, CWM603721S, CWM603722S, CWM603723S, CWM603927S, CWM603928S, CWM603930S, CWM6039

UPC codes

00763000001483

Source

Official record: FDA (Device enforcement) ↗

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