Icd-vr Dvex3e4 EV ICD Ev4 Pivotal recall
ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
Why was Icd-vr Dvex3e4 EV ICD Ev4 Pivotal recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00763000217891, Lot Serial Numbers: EVS600719S, EVS600271S, EVS600272S, EVS600273S, EVS600274S, EVS600322S, EVS600324S, EVS600325S, EVS600326S, EVS600366S, EVS600372S, EVS600503S, EVS600504S, EVS600529S, EVS600530S, EVS600531S, EVS600547S, EVS600548S, EVS600623S, EVS600558S, EVS600559S, EVS600560S, EVS600320S, EVS600549S, EVS600550S, EVS600551S, EVS600619S, EVS600620S, EVS600633S, EVS600635S, EVS600264S, EVS600338S, EVS600339S, EVS600546S, EVS600579S, EVS600337S, EVS600578S, EVS600580S, EVS600303S, EVS600304S, EVS600305S, EVS600306S, EVS600307S, EVS600308S, EVS600319S, EVS600332S, EVS600333S, EVS600335S, EVS600340S, EVS600373S, EVS600375S, EVS600376S, EVS600377S, EVS600378S, EVS600381S, EVS600485S, EVS600486S, EVS600496S, EVS600498S, EVS600532S, EVS600541S, EVS600542S, EVS600576S, EVS600577S, EVS600616S, EVS600617S, EVS600618S, EVS600275S, EVS600277S, EVS600279S, EVS600246S, EVS600247S, EVS600248S, EVS600251S, EVS600327S, EVS600328S, EVS600095S, EVS600096S, EVS600097S, EVS600098S, EVS600252S, EVS600255S, EVS600554S, EVS600555S, EVS600561S, EVS600566S, EVS600629S, EVS600258S, EVS600259S, EVS600260S, EVS600086S, EVS600094S, EVS600256S, EVS600263S, EVS600556S, EVS600557S, EVS600085S, EVS600262S, EVS600495S, EVS600568S, EVS600534S, EVS600285S, EVS600288S, EVS600569S, EVS600570S, EVS600638S, EVS600639S, EVS600640S, EVS600393S, EVS600418S, EVS600385S, EVS600015S, EVS600016S, EVS600027S, EVS600517S, EVS600011S, EVS600012S, EVS600013S, EVS600420S, EVS600421S, EVS600014S, EVS600028S, EVS600068S, EVS600069S, EVS600070S, EVS600071S, EVS600072S, EVS600074S, EVS600078S, EVS600505S, EVS600518S, EVS600520S, EVS600720S; GTIN 00763000217907, Lot Serial Numbers: EVS600396S, EVS600061S, EVS600218S, EVS600204S, EVS600407S, EVS600646S, EVS600645S, EVS600647S, EVS600648S, EVS600179S, EVS600397S, EVS600040S, EVS600044S, EVS600048S, EVS600049S, EVS600139S, EVS600140S, EVS600232S, EVS600039S, EVS600056S, EVS600150S, EVS600231S, EVS600344S, EVS600141S, EVS600165S, EVS600166S, EVS600368S, EVS600351S, EVS600353S, EVS600354S, EVS600389S, EVS600390S, EVS600032S, EVS600033S, EVS600034S, EVS600045S, EVS600076S, EVS600055S, EVS600178S, EVS600155S, EVS600134S, EVS600209S, EVS600210S, EVS600205S, EVS600357S, EVS600653S, EVS600654S, EVS600050S, EVS600149S, EVS600161S, EVS600162S, EVS600164S, EVS600212S, EVS600664S, EVS600657S, EVS600658S, EVS600051S, EVS600053S, EVS600135S, EVS600211S, EVS600234S, EVS600236S, EVS600343S, EVS600348S, EVS600349S, EVS600350S, EVS600411S, EVS600412S, EVS600659S, EVS600254S, EVS600031S, EVS600159S, EVS600415S, EVS600206S, EVS600655S, EVS600656S, EVS600035S, EVS600060S, EVS600063S, EVS600157S, EVS600180S, EVS600364S, EVS600365S, EVS600643S, EVS600671S, EVS600052S, EVS600169S, EVS600170S, EVS600177S, EVS600199S, EVS600201S, EVS600202S, EVS600203S, EVS600207S, EVS600208S, EVS600220S, EVS600221S, EVS600367S, EVS600369S, EVS600371S, EVS600374S, EVS600380S, EVS600382S, EVS600384S, EVS600399S, EVS600400S, EVS600403S, EVS600423S, EVS600642S, EVS600644S, EVS600668S, EVS600669S, EVS600670S, EVS600672S, EVS600058S, EVS600057S, EVS600167S, EVS600168S, EVS600214S, EVS600153S, EVS600154S, EVS600156S, EVS600182S, EVS600408S, EVS600370S, EVS600662S, EVS600075S, EVS600649S, EVS600650S, EVS600652S, EVS600663S, EVS600651S, EVS600064S, EVS600065S, EVS600073S, EVS600142S, EVS600216S, EVS600239S, EVS600136S, EVS600137S, EVS600138S, EVS600143S, EVS600144S, EVS600145S, EVS600146S, EVS600147S, EVS600148S, EVS600158S, EVS600171S, EVS600172S, EVS600175S, EVS600036S, EVS600037S, EVS600038S, EVS600054S, EVS600641S
- Product
- ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 289 units
- Distribution
- US Nationwide - Worldwide Distribution
- Recall date
- June 28, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)