--- title: "ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverte... — FDA record Z-1806-2023 | Is It on Recall" description: "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)" url: https://isitonrecall.com/recall/fda-device-z-1806-2023-icd-vr-visia-mri-af-xt-ous-df4-model-number-dvfb2d4-implantable-cardioverter-defibrillators/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators — FDA record Z-1806-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date May 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators - **Reason**: 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. - **Classification**: Class I - **Recalling firm**: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - **Quantity**: 15381 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1806-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1806-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | GTIN 00643169717992, Lot Serial Numbers: PLX607314S, PLX608121S, PLX612778S, PLX613087S, PLX604547S, PLX610926S, PLX606361S, PLX608125S, PLX610724S, PLX610983S, PLX609285S, PLX608127S, PLX608938S, PLX610866S, PLX612123S, PLX608086S, PLX608118S, PLX609410S, PLX610864S, PLX610961S, PLX610967S, PLX611934S, PLX611951S, PLX614024S, PLX614073S, PLX608054S, PLX605322S, PLX614114S, PLX607228S, PLX607330S, PLX607943S, PLX613085S, PLX609803S, PLX607928S, PLX605323S, PLX607310S, PLX607333S, PLX606750S, PLX608915S, PLX608983S, PLX609494S, PLX610736S, PLX610740S, PLX610953S, PLX610949S, PLX612097S, PLX608914S, PLX607332S, PLX607785S, PLX607788S, PLX609693S, PLX609858S, PLX608510S, PLX607200S, PLX610731S, PLX606698S, PLX607506S, PLX610276S, PLX606134S, PLX605235S, PLX606368S, PLX612749S, PLX607386S, 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00643169720800, Lot Serial numbers: PLX612879S, PLX613648S, PLX614366S, PLX612156S, PLX607872S, PLX611977S, PLX615851S, PLX613825S, PLX615377S, PLX614963S, PLX610427S, PLX616168S, PLX604202S, PLX604618S, PLX605160S, PLX605368S, PLX605485S, PLX605489S, PLX605493S, PLX605584S, PLX605922S, PLX605944S, PLX606024S, PLX606930S, PLX607094S, PLX607537S, PLX607599S, PLX607953S, PLX608085S, PLX608145S, PLX609262S, PLX609264S, PLX609562S, PLX610795S, PLX612528S, PLX612529S, PLX612601S, PLX612888S, PLX613321S, PLX615065S, PLX616025S, PLX616484S, PLX604539S, PLX610755S, PLX610756S, PLX611836S, PLX611839S, PLX611845S, PLX612013S, PLX607702S, PLX614047S, PLX611036S, PLX612868S, PLX606452S, PLX612263S, PLX606059S, PLX605046S, PLX607701S, PLX606056S, PLX609414S, PLX606062S, PLX612014S, PLX613142S, PLX615592S, PLX616188S, PLX616252S, PLX606211S, PLX604391S, PLX604507S, PLX605398S, PLX605558S, PLX606486S, PLX607250S, PLX607891S, PLX608756S, PLX610037S, PLX610208S, PLX613049S, PLX613294S, PLX613315S, 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PLX610662S, PLX610668S, PLX611469S, PLX611615S, PLX611827S, PLX611830S, PLX611886S, PLX611888S, PLX611916S, PLX612882S, PLX612919S, PLX613175S, PLX613253S, PLX613347S, PLX613814S, PLX613816S, PLX613866S, PLX614240S, PLX614265S, PLX614449S,... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1806-2023%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide - Worldwide Distribution States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jun 28, 2023 - **Recall initiation date**: May 10, 2023 - **Center classification date**: Jun 16, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1806-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) records](https://isitonrecall.com/brand/medtronic-inc-cardiac-rhythm-and-heart-failure-crhf/)