FDAFDA · Food and drugs·Recall number Z-1718-2023
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
Published June 28, 2023 · Recall initiated: May 10, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distributor
- US Nationwide - Worldwide Distribution
- Lot
- 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, CWN605032S, CWN606242S, CWN606359S, CWN607834S, CWN607835S, CWN607836S, CWN608620S, CWN608621S, CWN608622S, CWN608623S, CWN608624S, CWN608625S, CWN608626S, CWN608628S, CWN608629S, CWN609636S, CWN609637S, CWN609638S, CWN609639S, CWN609640S, CWN609641S, CWN609642S, CWN607664S, CWN608090S, CWN611266S, CWN611279S, CWN611280S, CWN611281S, CWN611282S, CWN611283S, CWN611284S, CWN603096S, CWN603173S, CWN603182S, CWN603316S, CWN603317S, CWN603384S, CWN603385S, CWN603386S, CWN603457S, CWN603473S, CWN603475S, CWN603477S, CWN603557S, CWN603559S, CWN603560S, CWN604127S, CWN604276S, CWN604281S, CWN604282S, CWN604377S, CWN604378S, CWN604379S, CWN604380S, CWN604927S, CWN604930S, CWN605290S, CWN605292S, CWN605296S, CWN605298S, CWN605381S, CWN605658S, CWN605659S, CWN605756S, CWN605757S, CWN605758S, CWN605760S, CWN605761S, CWN605896S, CWN605899S, CWN605903S, CWN605904S, CWN606201S, CWN606209S, CWN606210S, CWN606584S, CWN606590S, CWN606591S, CWN606928S, CWN606929S, CWN606933S, CWN606936S, CWN606942S, CWN607232S, CWN607234S, CWN607306S, CWN607312S, CWN607494S, CWN607495S, CWN607521S, CWN607532S, CWN607541S, CWN607542S, CWN607920S, CWN607921S, CWN607922S, CWN607923S, CWN607924S, CWN607925S, CWN608505S, CWN608600S, CWN608601S, CWN608602S, CWN608603S, CWN608604S, CWN608606S, CWN608607S, CWN608608S, CWN608609S, CWN608611S, CWN608612S, CWN608614S, CWN608616S, CWN608618S, CWN608619S, CWN608738S, CWN608739S, CWN608740S, CWN609720S, CWN609721S, CWN609722S, CWN609723S, CWN609724S, CWN609725S, CWN609726S, CWN609727S, CWN609728S, CWN609729S, CWN609730S, CWN609731S, CWN609732S, CWN609733S, CWN611267S, CWN611268S, CWN611269S, CWN611270S, CWN611271S, CWN611272S, CWN611273S, CWN611274S, CWN611275S, CWN611276S, CWN611277S, CWN611278S, CWN611434S, CWN611435S, CWN611436S, CWN611437S, CWN611438S, CWN604395S, CWN604396S, CWN604397S, CWN604398S, CWN604399S, CWN605974S, CWN605979S, CWN605995S, CWN606005S, CWN604887S, CWN603222S, CWN609751S, CWN605416S, CWN605335S, CWN604520S, CWN605423S, CWN605424S, CWN605137S, CWN606047S, CWN606257S, CWN606564S, CWN606740S, CWN603503S, CWN603603S, CWN604300S, CWN606337S, CWN609573S, CWN605626S, CWN607331S, CWN608333S, CWN605670S, CWN610335S, CWN602548S, CWN603186S, CWN603731S, CWN604997S, CWN607354S, CWN603725S, CWN601505S, CWN603255S, CWN606092S, CWN607703S, CWN608168S, CWN603226S, CWN603737S, CWN604075S, CWN605198S, CWN601065S, CWN601066S, CWN601260S, CWN601763S, CWN601956S, CWN602953S, CWN602955S, CWN602989S, CWN603380S, CWN603815S, CWN604024S, CWN604034S, CWN604841S
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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