Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; 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: 404 units Lot/code info: GTIN 00763000178260, Lot Serial Numbers: RTT600077S, RTT600166S, RTT600169S, RTT600064S, RTT600083S, RTT600071S, RTT600042S, RTT600028S, RTT600107S, RTT600034S, RTT600421S, RTT600432S, RTT600434S, RTT600574S, RTT600161S, RTT600054S, RTT600160S, RTT600231S, RTT600431S, RTT600045S, RTT600165S, RTT600022S, RTT600062S, RTT600091S, RTT600195S, RTT600430S, RTT600437S, RTT600438S, RTT600125S, RTT600533S, RTT600427S, RTT600481S, RTT600111S, RTT600128S, RTT600040S, RTT600066S, RTT600046S, RTT600573S, RTT600322S, RTT600076S, RTT600024S, RTT600134S, RTT600150S, RTT600531S, RTT600047S, RTT600086S, RTT600220S, RTT600059S, RTT600063S, RTT600426S, RTT600530S, RTT600075S, RTT600095S, RTT600149S, RTT600537S, RTT600541S, RTT600546S, RTT600549S, RTT600550S, RTT600552S, RTT600716S, RTT600889S, RTT600093S, RTT600057S, RTT600156S, RTT600157S, RTT600037S, RTT600429S, RTT600236S, RTT600422S, RTT600436S, RTT600143S, RTT600507S, RTT600065S, RTT600072S, RTT600435S, RTT600056S, RTT600073S, RTT600098S, RTT600067S, RTT600425S, RTT600081S, RTT600035S, RTT600527S, RTT600087S, RTT600433S, RTT600140S, RTT600167S, RTT600168S, RTT600089S, RTT600103S, RTT600030S, RTT600061S, RTT600420S, RTT600566S, RTT600567S; GTIN 00763000178284, Lot Serial Numbers: RTT600985S, RTT600411S, RTT600879S, RTT600925S, RTT601085S, RTT600918S, RTT600632S, RTT600977S, RTT600367S, RTT600456S, RTT600459S, RTT600389S, RTT600323S, RTT600351S, RTT600453S, RTT600356S, RTT600360S, RTT600377S, RTT600558S, RTT600577S, RTT600547S, RTT600314S, RT

UPC codes

00763000178260, 00763000178284

Source

Official record: FDA (Device enforcement) ↗

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