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Crome HF CRT-D MRI SureScan recallZ-1786-2023 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated May 10, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

Medtronic issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/10/2023 by UPS 2-day delivery or email. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. The notice explained the problem and the risk and requested the following patient management recommendations: - Prophylactic device replacement is NOT recommended. - Program all HV therapy pathways B>AX in all therapy zones to minimize the risk for this issue. - Prioritize reprogramming patients who have both a history of HV therapy and Rx1 programmed AX>B. - For remaining patients with AX>B programming in any HV therapy sequence, schedule (with appropriate discretion) the next follow-up for in-clinic reprogramming to minimize potential for reduced- or no-energy HV therapies to occur. - Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue: o Reduced- or no-energy HV therapy is displayed in Episode Text (regardless of programmed pathway) o A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy. Update 10/10/2023: Beginning 09/27/2023, Medtronic issued communication via letter to consignees regarding the availability of the revised IFU and SmartSync Software. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.

Recall details

Recall number
Z-1786-2023
Status
Open, Classified
Initiated by the company
May 10, 2023
Posted by the FDA
Jun 16, 2023
Recalling firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity
476 units
Product code
NIK
FDA submissions
P010031S674
Distribution
US Nationwide - Worldwide Distribution

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (6k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92328).

Sources and updates

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