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Permanent Defibrillator Electrodes

FDA product code NVY · Class 3 · Unknown

465
Registered devices
139,553
Adverse events
5
Recalls
0
510(k) clearances

Devices with this code

SPRINT QUATTRO® — MEDTRONIC, INC.Linox Smart S 75 — BIOTRONIK SE & Co. KGCAPSURE®SP NOVUS — MEDTRONIC, INC.CAPSURE®SP NOVUS — MEDTRONIC, INC.Sprint Quattro Secure MRI™ SureScan™ — MEDTRONIC, INC.VOLTA — BIOTRONIK SE & Co. KGCAPSUREFIX® NOVUS — MEDTRONIC, INC.SPRINT QUATTRO SECURE S™ DXAC/DSP — MEDTRONIC, INC.Pamira S 65 — BIOTRONIK SE & Co. KGSprint Quattro Secure® — MEDTRONIC, INC.OmniaSecure™ MRI SureScan™ — MEDTRONIC, INC.Sprint Quattro Secure S® — MEDTRONIC, INC.Plexa ProMRI — BIOTRONIK SE & Co. KGSprint Quattro® — MEDTRONIC, INC.ENDOTAK RELIANCE® S — BOSTON SCIENTIFIC CORPORATIONCAPSUREFIX® NOVUS — MEDTRONIC, INC.CapSureFix Novus MRI™ SureScan® — MEDTRONIC, INC.ENDOTAK RELIANCE® — BOSTON SCIENTIFIC CORPORATIONOPTISURE¿™ — ST. JUDE MEDICAL, INC.Durata™ — ST. JUDE MEDICAL, INC.OPTISURE™ — ST. JUDE MEDICAL, INC.SPRINT QUATTRO® — MEDTRONIC, INC.OPTISURE™ — ST. JUDE MEDICAL, INC.Sprint Quattro Secure® — MEDTRONIC, INC.

Recent recalls

DateFirmReason
2025-07-24Boston Scientific CorporationAffected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to
2025-07-24Boston Scientific CorporationAffected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to
2022-09-30Boston Scientific CorporationThere is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
2022-09-30Boston Scientific CorporationThere is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
2021-11-08Medtronic 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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.