Home › Device types › NVY
Permanent Defibrillator Electrodes
FDA product code NVY · Class 3 · Unknown
465
Registered devices
137,709
Adverse events
5
Recalls
0
510(k) clearances
Devices with this code
VOLTA — BIOTRONIK SE & Co. KGCAPSURE SP NOVUS® — MEDTRONIC, INC.Sprint Quattro Secure S MRI™ SureScan™ — MEDTRONIC, INC.Durata™ — ST. JUDE MEDICAL, INC.Capsurefix® Novus — MEDTRONIC, INC.CapSure Sense® — MEDTRONIC, INC.Sprint Quattro® — MEDTRONIC, INC.CapSure Sense® — MEDTRONIC, INC.SPRINT QUATTRO® — MEDTRONIC, INC.CapSureFix Novus MRI™ SureScan™ — MEDTRONIC, INC.Sprint Quattro Secure® — MEDTRONIC, INC.Sprint Quattro Secure S® — MEDTRONIC, INC.CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.Protego — BIOTRONIK SE & Co. KGCapSure Sense MRI™ SureScan™ — MEDTRONIC, INC.CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.Sprint Quattro Secure™ — MEDTRONIC, INC.Plexa — BIOTRONIK SE & Co. KGCAPSUREFIX® NOVUS — MEDTRONIC, INC.Sprint Quattro Secure® — MEDTRONIC, INC.CAPSURE® SENSE — MEDTRONIC, INC.Tendril™ — ST. JUDE MEDICAL, INC.Sprint Quattro Secure® — MEDTRONIC, INC.CapSureFix Novus MRI™ SureScan™ — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-24 | Boston Scientific Corporation | Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to |
| 2025-07-24 | Boston Scientific Corporation | Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to |
| 2022-09-30 | Boston Scientific Corporation | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. |
| 2022-09-30 | Boston Scientific Corporation | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. |
| 2021-11-08 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a c |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.