Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; 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: 487 units Lot/code info: GTIN 00763000178413, Lot Serial Numbers: RSP600249S, RSP600057S, RSP600253S, RSP600085S, RSP600014S, RSP600150S, RSP600148S, RSP600089S, RSP600091S, RSP600114S, RSP600189S, RSP600210S, RSP600394S, RSP600130S, RSP600216S, RSP600256S, RSP600386S, RSP600149S, RSP600245S, RSP600066S, RSP600068S, RSP600069S, RSP600083S, RSP600112S, RSP600132S, RSP600136S, RSP600404S, RSP600076S, RSP600731S, RSP600954S, RSP600955S, RSP600953S, RSP600070S, RSP600145S, RSP600157S, RSP600200S, RSP600226S, RSP600082S, RSP600139S, RSP600141S, RSP600152S, RSP600163S, RSP600074S, RSP600732S, RSP600204S, RSP600369S, RSP600726S, RSP600748S, RSP600048S, RSP600080S, RSP600363S, RSP600396S, RSP600397S, RSP600408S, RSP600444S, RSP600544S, RSP600335S, RSP600383S, RSP600400S, RSP600808S, RSP600862S, RSP600939S, RSP600949S, RSP600950S, RSP600218S, RSP600288S, RSP600246S, RSP600193S, RSP600395S, RSP600725S, RSP600360S, RSP600413S, RSP600202S, RSP600736S, RSP600138S, RSP600049S, RSP600065S, RSP600095S, RSP600346S, RSP600372S, RSP600059S, RSP600219S, RSP600079S, RSP600190S, RSP600398S, RSP600217S, RSP600230S, RSP600723S, RSP600203S, RSP600221S, RSP600187S, RSP600250S, RSP600276S, RSP600060S, RSP600267S, RSP600392S, RSP600813S, RSP600154S, RSP600209S, RSP600211S, RSP600224S, RSP600729S, RSP600758S, RSP600134S, RSP600096S, RSP600734S, RSP600273S, RSP600722S, RSP600945S, RSP600946S; GTIN 00763000178420, Lot Serial Numbers: RSP600738S, RSP601022S, RSP600759S, RSP600761S, RSP600976S, RSP600984S, RSP601035S, RSP601038S, RS

UPC codes

00763000178413, 00763000178420

Source

Official record: FDA (Device enforcement) ↗

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