FDA Device recall Z-1803-2023
ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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 resynch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1803-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-10 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; 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.
Identifiers
| code_info | GTIN 00643169837799, Lot Serial Numbers: CWG208686H, CWG211264H, CWG205930H, CWG208117H, CWG210956H, CWG210958H, CWG21…GTIN 00643169837799, Lot Serial Numbers: CWG208686H, CWG211264H, CWG205930H, CWG208117H, CWG210956H, CWG210958H, CWG211814H, CWG212178H, CWG208135H, CWG209489H, CWG209599H, CWG212702H, CWG214349H, CWG214379H, CWG206584H, CWG208347H, CWG206776H, CWG206895H, CWG211478H, CWG211709H, CWG212079H, CWG212183H, CWG212836H, CWG205283H, CWG205284H, CWG205288H, CWG207805H, CWG207808H, CWG207809H, CWG207810H, CWG207811H, CWG207812H, CWG208949H, CWG209030H, CWG209031H, CWG209285H, CWG209646H, CWG209659H, CWG209823H, CWG210928H, CWG210929H, CWG211866H, CWG212840H, CWG212841H, CWG212842H, CWG212843H, CWG212844H, CWG212846H, CWG212847H, CWG212851H, CWG212853H, CWG212854H, CWG213620H, CWG213622H, CWG213623H, CWG206242H, CWG206868H, CWG209799H, CWG212914H, CWG205298H, CWG205299H, CWG205450H, CWG205777H, CWG206838H, CWG206972H, CWG208335H, CWG208502H, CWG209280H, CWG209978H, CWG209979H, CWG209981H, CWG209982H, CWG209983H, CWG211070H, CWG211071H, CWG211072H, CWG211696H, CWG212566H, CWG212568H, CWG212569H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1803-2023%22
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