Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; 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: 664 units Lot/code info: GTIN 00643169837706, Lot Serial Numbers: RPW200770H, RPW200730H, RPW201054H, RPW200583H, RPW200593H, RPW200970H, RPW201002H, RPW201095H, RPW200917H, RPW201040H, RPW201026H, RPW200661H, RPW200981H, RPW200665H, RPW200741H, RPW200743H, RPW200908H, RPW200971H, RPW200600H, RPW200635H, RPW200638H, RPW200652H, RPW200657H, RPW200660H, RPW200761H, RPW200800H, RPW200803H, RPW200822H, RPW200827H, RPW200714H, RPW200809H, RPW200548H, RPW201023H, RPW201103H, RPW200575H, RPW200794H, RPW200807H, RPW200994H, RPW201055H, RPW200630H, RPW200659H, RPW200904H, RPW201079H, RPW201171H, RPW200578H, RPW200695H, RPW200621H, RPW201015H, RPW201084H, RPW201151H, RPW201153H, RPW200590H, RPW200938H, RPW200582H, RPW200847H, RPW200870H, RPW200683H, RPW200685H, RPW200754H, RPW200852H, RPW200585H, RPW200648H, RPW200669H, RPW200673H, RPW200721H, RPW200839H, RPW200879H, RPW200882H, RPW201041H, RPW201140H, RPW201161H, RPW200692H, RPW200863H, RPW200881H, RPW200969H, RPW201032H, RPW200553H, RPW200543H, RPW200595H, RPW200686H, RPW200698H, RPW200738H, RPW200750H, RPW200753H, RPW200804H, RPW200813H, RPW200838H, RPW200894H, RPW201133H, RPW200556H, RPW200855H, RPW200626H, RPW200646H, RPW200711H, RPW201080H, RPW200577H, RPW201088H, RPW200653H, RPW200605H, RPW200728H, RPW200889H, RPW200890H, RPW200964H, RPW200977H, RPW201012H, RPW201139H, RPW200552H, RPW200764H, RPW200833H, RPW200857H, RPW200858H, RPW200688H, RPW200561H, RPW200825H, RPW200625H, RPW200703H, RPW200746H, RPW200846H, RPW201108H, RPW200664H, RPW201129H, RPW2010

UPC codes

00643169837706, 00763000060091

Source

Official record: FDA (Device enforcement) ↗

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