--- title: "ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardiover... — FDA record Z-1793-2023 | 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-1793-2023-icd-vr-visia-af-s-us-ous-is1-df1-model-number-dvac3d1-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 AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators — FDA record Z-1793-2023 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 AF S US/OUS IS1/DF1, Model Number DVAC3D1; 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**: 176 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1793-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1793-2023%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 00643169720770, Lot Serial numbers: BWU600672S, BWU600685S, BWU600654S, BWU600656S, BWU600555S, BWU600638S, BWU600641S, BWU600642S, BWU600647S, BWU600648S, BWU600650S, BWU600651S, BWU600664S, BWU600643S, BWU600645S, BWU600557S, BWU600556S, BWU600763S, BWU600640S, BWU600639S, BWU600649S, BWU600661S, BWU600662S, BWU600663S, BWU600665S, BWU600666S, BWU600671S, BWU600673S, BWU600676S, BWU600646S, BWU600652S, BWU600653S, BWU600655S, BWU600658S, BWU600659S, BWU600667S, BWU600668S, BWU600669S, BWU600684S, BWU600694S, BWU600695S, BWU600696S, BWU600697S, BWU600698S, BWU600699S, BWU600700S, BWU600701S, BWU600702S, BWU600703S, BWU600707S, BWU600708S, BWU600709S, BWU600710S, BWU600711S, BWU600714S, BWU600715S, BWU600716S, BWU600739S, BWU600741S, BWU600758S, BWU600760S, BWU600761S, BWU600762S, BWU600764S, BWU600765S, BWU600766S, BWU600712S, BWU600644S; GTIN 00763000052713, Lot Numbers: BWU600776S, BWU600721S, BWU600810S, BWU600771S, BWU600772S, BWU600774S, BWU600723S, BWU600795S, BWU600820S, BWU600720S, BWU600782S, BWU600768S, BWU600719S, BWU600793S, BWU600717S, BWU600718S, BWU600722S, BWU600726S, BWU600727S, BWU600728S, BWU600729S, BWU600730S, BWU600735S, BWU600778S, BWU600807S, BWU600808S, BWU600809S, BWU600813S, BWU600814S, BWU600815S, BWU600816S, BWU600817S, BWU600819S, BWU600821S, BWU600822S, BWU600830S, BWU600831S, BWU600833S, BWU600834S, BWU600835S, BWU600836S, BWU600704S, BWU600705S, BWU600736S, BWU600767S, BWU600806S, BWU600848S, BWU600849S, BWU600850S, BWU600870S, BWU600876S, BWU600936S, BWU600937S, BWU600939S, BWU600940S, BWU600941S, BWU600769S, BWU600770S, BWU600841S, BWU600845S, BWU600847S, BWU600852S, BWU600853S, BWU600855S, BWU600856S, BWU600860S, BWU600862S, BWU600864S, BWU600869S, BWU600872S, BWU600827S, BWU600828S, BWU600877S, BWU600880S, BWU600886S, BWU600888S, BWU600891S, BWU600893S, BWU600897S, BWU600905S, BWU600907S, BWU600909S, BWU600915S, BWU600916S, BWU600917S, BWU600918S, BWU600919S, BWU600920S, BWU600921S, BWU600775S, BWU600788S, BWU600804S, BWU600777S, BWU600779S, BWU600805S, BWU600832S, BWU600930S, BWU600931S, BWU600914S, BWU600942S, BWU600943S, BWU600944S, BWU600945S, BWU600947S, BWU600951S, BWU600953S, BWU600955S, BWU600956S | 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-1793-2023%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/)