FDAClass IJune 28, 2023

Crtd Crome HF MRI Is1 Df4 recall

CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators

Why was Crtd Crome HF MRI Is1 Df4 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 00763000178291, Lot Serial numbers: RTW600585S, RTW600307S, RTW600091S, RTW600313S, RTW600121S, RTW600342S, RTW600596S, RTW600074S, RTW600144S, RTW600102S, RTW600319S, RTW600578S, RTW600346S, RTW600277S, RTW600309S, RTW600581S, RTW600098S, RTW600118S, RTW600119S, RTW600123S, RTW600133S, RTW600138S, RTW600159S, RTW600168S, RTW600205S, RTW600052S, RTW600067S, RTW600217S, RTW600333S, RTW600592S, RTW600059S, RTW600151S, RTW600169S, RTW600196S, RTW600229S, RTW600304S, RTW600306S, RTW600223S, RTW600062S, RTW600171S, RTW600049S, RTW600057S, RTW600126S, RTW600130S, RTW600153S, RTW600158S, RTW600163S, RTW600181S, RTW600182S, RTW600188S, RTW600204S, RTW600211S, RTW600230S, RTW600240S, RTW600245S, RTW600247S, RTW600249S, RTW600250S, RTW600317S, RTW600323S, RTW600338S, RTW600588S, RTW600589S, RTW600593S, RTW600339S, RTW600819S, RTW600113S, RTW600594S, RTW600120S, RTW600244S, RTW600008S, RTW600056S, RTW600089S, RTW600183S, RTW600239S, RTW600292S, RTW600297S, RTW600069S, RTW600148S, RTW600080S, RTW600156S, RTW600179S, RTW600094S, RTW600127S, RTW600161S, RTW600813S, RTW600068S, RTW600110S, RTW600149S, RTW600237S, RTW600345S, RTW600591S, RTW600082S, RTW600087S, RTW600090S, RTW600350S, RTW600358S, RTW600362S, RTW600363S, RTW600365S, RTW600054S, RTW600075S, RTW600347S, RTW600619S, RTW600620S, RTW600624S, RTW600625S, RTW600628S, RTW600630S, RTW600634S, RTW600637S, RTW600640S, RTW600641S, RTW600643S, RTW600648S, RTW600649S, RTW600650S, RTW600651S, RTW600654S, RTW600655S, RTW600658S, RTW600662S, RTW600663S, RTW600664S, RTW600670S, RTW600672S, RTW600673S, RTW600743S, RTW600758S, RTW600759S, RTW600777S, RTW600818S, RTW600820S, RTW600330S, RTW600331S, RTW600125S, RTW600160S, RTW600053S, RTW600595S, RTW600065S, RTW600109S, RTW600136S, RTW600147S, RTW600200S, RTW600308S, RTW600085S, RTW600175S, RTW600228S, RTW600332S, RTW600073S, RTW600172S, RTW600315S, RTW600143S, RTW600165S, RTW600187S, RTW600213S, RTW600584S, RTW600048S, RTW600164S, RTW600586S, RTW600097S, RTW600129S, RTW600195S, RTW600254S, RTW600114S, RTW600343S, RTW600101S, RTW600116S, RTW600104S, RTW600811S, RTW600812S; GTIN 00763000178314, Lot Serial Numbers: RTW600542S, RTW600770S, RTW600943S, RTW600680S, RTW600805S, RTW600918S, RTW600611S, RTW600681S, RTW600688S, RTW600782S, RTW600635S, RTW600614S, RTW600653S, RTW600913S, RTW600484S, RTW600716S, RTW600405S, RTW600413S, RTW600721S, RTW600804S, RTW600744S, RTW600404S, RTW600496S, RTW600535S, RTW600505S, RTW600774S, RTW600888S, RTW600494S, RTW600526S, RTW600557S, RTW600335S, RTW600497S, RTW600521S, RTW600882S, RTW600486S, RTW600540S, RTW600603S, RTW600407S, RTW600500S, RTW600522S, RTW600608S, RTW600797S, RTW600038S, RTW600321S, RTW600410S, RTW600510S, RTW600397S, RTW600852S, RTW600536S, RTW600684S, RTW600691S, RTW600740S, RTW600545S, RTW600550S, RTW600742S, RTW600750S, RTW600441S, RTW600731S, RTW600493S, RTW600415S, RTW600492S, RTW600607S, RTW600671S, RTW600456S, RTW600686S, RTW600687S, RTW600718S, RTW600934S, RTW600512S, RTW600604S, RTW600714S, RTW600666S, RTW600705S, RTW600775S, RTW600022S, RTW600316S, RTW600340S, RTW600465S, RTW600720S, RTW600412S, RTW600753S, RTW600538S, RTW600702S, RTW600537S, RTW600555S, RTW600703S, RTW600707S, RTW600393S, RTW600549S, RTW600623S, RTW600318S, RTW600336S, RTW600388S, RTW600469S, RTW600334S, RTW600669S, RTW600856S, RTW600899S, RTW600631S, RTW600908S, RTW600909S, RTW600470S, RTW600488S, RTW600509S, RTW600539S, RTW600615S, RTW600642S, RTW600715S, RTW600552S, RTW600661S, RTW600728S, RTW600767S, RTW600636S, RTW600487S, RTW600516S, RTW600502S, RTW600848S, RTW600749S, RTW600554S, RTW600408S, RTW600495S, RTW600517S, RTW600689S, RTW600660S, RTW600723S, RTW600769S, RTW600838S, RTW600906S, RTW600543S, RTW600561S, RTW600692S, RTW600746S, RTW600466S, RTW600467S, RTW600553S, RTW600647S, RTW600490S, RTW600232S, RTW600392S, RTW600395S, RTW600513S, RTW600032S, RTW600361S, RTW600421S, RTW600433S, RTW600436S, RTW600828S, RTW600400S, RTW600518S, RTW600645S, RTW600695S, RTW600341S, RTW600387S, RTW600419S, RTW600394S, RTW600461S, RTW600463S, RTW600514S, RTW600755S, RTW600364S, RTW600389S, RTW600398S, RTW600399S, RTW600403S, RTW600417S, RTW600420S, RTW600427S, RTW600428S, RTW600489S, RTW600508S, RTW600519S, RTW600523S, RTW600529S, RTW600530S, RTW600626S, RTW600694S, RTW600698S, RTW600712S, RTW600727S, RTW600748S, RTW600778S, RTW600781S, RTW600889S, RTW600911S, RTW600515S, RTW600697S, RTW600713S, RTW600847S, RTW600040S, RTW600041S, RTW600045S, RTW600324S, RTW600344S, RTW600422S, RTW600474S, RTW600478S, RTW600479S, RTW600480S, RTW600507S, RTW600527S, RTW600679S, RTW600690S, RTW600784S, RTW600832S, RTW600600S, RTW600601S, RTW600602S, RTW600605S, RTW600610S, RTW600617S, RTW600618S, RTW600453S, RTW600454S, RTW600425S, RTW600426S, RTW600459S, RTW600511S, RTW600524S, RTW600528S, RTW600531S, RTW600534S, RTW600582S, RTW600597S, RTW600450S, RTW600580S, RTW600613S, RTW600020S, RTW600498S, RTW600556S, RTW600471S, RTW600883S, RTW600034S, RTW600359S, RTW600360S, RTW600018S, RTW600396S, RTW600559S, RTW600752S, RTW600783S, RTW600033S, RTW600668S, RTW600754S, RTW600025S, RTW600546S, RTW600710S, RTW600730S, RTW600765S, RTW600351S, RTW600547S, RTW600677S, RTW600700S, RTW600806S, RTW600855S, RTW600444S, RTW600445S, RTW600504S, RTW600027S, RTW600028S, RTW600029S, RTW600356S, RTW600390S, RTW600476S, RTW600430S, RTW600739S, RTW600795S, RTW600482S, RTW600598S, RTW600616S, RTW600685S, RTW600693S, RTW600704S, RTW600737S, RTW600745S, RTW600766S, RTW600771S, RTW600780S, RTW600792S, RTW600799S, RTW600839S, RTW600850S, RTW600859S, RTW600865S, RTW600866S, RTW600885S, RTW600891S, RTW600893S, RTW600904S, RTW600912S, RTW600929S, RTW600932S, RTW600933S, RTW600937S, RTW600954S, RTW600966S, RTW601008S, RTW600533S, RTW600541S, RTW600544S, RTW600587S, RTW600599S, RTW600786S, RTW600791S, RTW600854S, RTW600894S, RTW600921S

Product
CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
Recalling firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity
476 units
Distribution
US Nationwide - Worldwide Distribution
Recall date
June 28, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls