Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; 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: 61,404 units Lot/code info: GTIN 00643169720497, Lot Serial Numbers: PFZ236436H, PFZ242339H, PFZ247708H, PFZ247891H, PFZ250783H, PFZ252117H, PFZ259560H, PFZ265053H, PFZ271895H, PFZ248688H, PFZ254957H, PFZ260373H, PFZ273832H, PFZ244136H, PFZ245315H, PFZ264212H, PFZ271087H, PFZ273388H, PFZ238454H, PFZ242886H, PFZ245032H, PFZ245482H, PFZ251539H, PFZ251620H, PFZ254361H, PFZ256071H, PFZ258481H, PFZ259582H, PFZ261497H, PFZ263430H, PFZ264999H, PFZ268418H, PFZ269828H, PFZ274151H, PFZ236422H, PFZ239293H, PFZ240140H, PFZ242722H, PFZ244519H, PFZ244850H, PFZ246467H, PFZ247093H, PFZ248638H, PFZ250072H, PFZ250429H, PFZ251666H, PFZ263854H, PFZ268573H, PFZ268973H, PFZ240263H, PFZ242174H, PFZ247965H, PFZ263650H, PFZ268685H, PFZ270530H, PFZ240280H, PFZ240282H, PFZ240283H, PFZ240284H, PFZ240285H, PFZ240286H, PFZ240287H, PFZ240288H, PFZ240292H, PFZ240294H, PFZ240295H, PFZ240296H, PFZ245429H, PFZ245430H, PFZ245435H, PFZ245437H, PFZ253305H, PFZ253306H, PFZ253312H, PFZ253315H, PFZ253317H, PFZ253318H, PFZ256364H, PFZ256365H, PFZ256366H, PFZ256367H, PFZ256368H, PFZ256371H, PFZ257391H, PFZ261794H, PFZ270374H, PFZ271142H, PFZ271143H, PFZ236326H, PFZ236764H, PFZ237716H, PFZ238433H, PFZ243679H, PFZ244764H, PFZ246310H, PFZ246566H, PFZ246737H, PFZ247439H, PFZ249902H, PFZ249948H, PFZ261645H, PFZ263628H, PFZ263982H, PFZ264671H, PFZ266539H, PFZ273368H, PFZ274260H, PFZ242175H, PFZ243885H, PFZ243969H, PFZ243986H, PFZ244929H, PFZ251483H, PFZ256616H, PFZ260183H, PFZ260192H, PFZ261455H, PFZ266251H, PFZ273240H, PFZ274766H, PFZ269396H, PFZ2715

UPC codes

00643169720497

Source

Official record: FDA (Device enforcement) ↗

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