Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; 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: 35,961 units Lot/code info: GTIN 00643169443419, Lot Serial Numbers: PGZ624363S, PGZ631078S, PGZ638449S, PGZ638465S, PGZ623851S, PGZ645877S, PGZ621671S, PGZ621673S, PGZ623094S, PGZ623561S, PGZ623984S, PGZ623985S, PGZ623986S, PGZ623991S, PGZ624447S, PGZ626933S, PGZ626995S, PGZ627005S, PGZ627071S, PGZ629198S, PGZ629204S, PGZ629217S, PGZ631034S, PGZ631035S, PGZ631036S, PGZ631037S, PGZ633073S, PGZ633357S, PGZ633680S, PGZ635203S, PGZ635731S, PGZ635749S, PGZ635812S, PGZ635815S, PGZ635820S, PGZ637440S, PGZ637885S, PGZ637919S, PGZ637947S, PGZ637950S, PGZ638090S, PGZ638096S, PGZ638463S, PGZ641070S, PGZ641071S, PGZ641072S, PGZ641083S, PGZ641140S, PGZ641168S, PGZ641651S, PGZ641687S, PGZ642430S, PGZ643962S, PGZ645328S, PGZ622752S, PGZ626967S, PGZ629552S, PGZ630964S, PGZ631210S, PGZ632646S, PGZ637386S, PGZ641102S, PGZ643196S, PGZ644010S, PGZ629356S, PGZ632534S, PGZ636328S, PGZ636330S, PGZ637349S, PGZ638180S, PGZ638396S, PGZ641545S, PGZ641547S, PGZ623932S, PGZ624470S, PGZ629461S, PGZ630997S, PGZ631127S, PGZ636208S, PGZ638240S, PGZ640023S, PGZ641657S, PGZ641677S, PGZ632771S, PGZ630319S, PGZ637994S, PGZ622780S, PGZ622781S, PGZ624036S, PGZ627292S, PGZ628782S, PGZ629050S, PGZ631254S, PGZ633614S, PGZ638098S, PGZ638275S, PGZ638285S, PGZ640025S, PGZ641095S, PGZ641108S, PGZ642879S, PGZ629852S, PGZ630137S, PGZ632260S, PGZ632544S, PGZ633391S, PGZ636391S, PGZ636395S, PGZ637895S, PGZ638445S, PGZ641662S, PGZ643042S, PGZ624374S, PGZ628984S, PGZ640903S, PGZ641175S, PGZ643167S, PGZ621685S, PGZ623066S, PGZ623584S, PGZ623887S, PGZ6240

UPC codes

00643169443419

Source

Official record: FDA (Device enforcement) ↗

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