Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328
Description: ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1793-2023 |
| Event ID | 92328 |
| Event Description | ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators |
| Product Type | Devices |
| Distribution | US Nationwide - Worldwide Distribution |
| Quantity | 176 units |
| Recall 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. |
| Device Classification | 20230628 |
| Device Code Info | 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 |
| Center Classification Date | 20230616 |
| Recall Initiation Date | 20230510 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
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