Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; 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: 11,239 units Lot/code info: GTIN 00763000001506, Lot Serial Numbers: CWN606940S, CWN606941S, CWN606806S, CWN609866S, CWN607173S, CWN607174S, CWN606850S, CWN605016S, CWN605224S, CWN605226S, CWN602473S, CWN605696S, CWN606066S, CWN601517S, CWN610794S, CWN611698S, CWN611709S, CWN611042S, CWN611699S, CWN608530S, CWN611057S, CWN611194S, CWN611137S, CWN611173S, CWN611168S, CWN610989S, CWN610994S, CWN610999S, CWN608676S, CWN610063S, CWN608932S, CWN609322S, CWN610602S, CWN608143S, CWN610351S, CWN611528S, CWN611651S, CWN607995S, CWN611583S, CWN608694S, CWN611439S, CWN611468S, CWN611541S, CWN611395S, CWN608844S, CWN611563S, CWN611417S, CWN608827S, CWN608184S, CWN608185S, CWN607983S, CWN609341S, CWN612034S, CWN610308S, CWN609462S, CWN608691S, CWN611586S, CWN611558S, CWN611650S, CWN611477S, CWN611385S, CWN611576S, CWN608837S, CWN608405S, CWN610408S, CWN611574S, CWN611547S, CWN611599S, CWN611554S, CWN603401S, CWN603403S, CWN603404S, CWN603405S, CWN603407S, CWN603408S, CWN603409S, CWN603516S, CWN603517S, CWN603518S, CWN603521S, CWN603779S, CWN603780S, CWN603785S, CWN603786S, CWN603944S, CWN603945S, CWN603955S, CWN603965S, CWN604184S, CWN604203S, CWN604223S, CWN604232S, CWN605362S, CWN605449S, CWN605556S, CWN605559S, CWN605561S, CWN605562S, CWN605577S, CWN605624S, CWN605640S, CWN605642S, CWN605644S, CWN605645S, CWN605650S, CWN605651S, CWN605655S, CWN605677S, CWN605678S, CWN606462S, CWN606463S, CWN606464S, CWN606712S, CWN606713S, CWN606727S, CWN606731S, CWN606732S, CWN606773S, CWN601994S, CWN602772S, CWN603379S, CWN6050

UPC codes

00763000001506

Source

Official record: FDA (Device enforcement) ↗

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