Permanent Defibrillator Electrodes
FDA product code NVY · Class III (high risk) · Cardiovascular
Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle.
0510(k) clearances
2PMA approvals
5recalls
Implantimplanted device
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2327-2025 Class I | RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead…Affected lead models may experience gradually rising LVSI measurements in association with calcification of… | Boston Scientific Corporation | 07/24/2025Open, Classified |
| Z-2326-2025 Class I | ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent…Affected lead models may experience gradually rising LVSI measurements in association with calcification of… | Boston Scientific Corporation | 07/24/2025Open, Classified |
| Z-0152-2023 Class II | EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of… | Boston Scientific Corporation | 09/30/2022Open, Classified |
| Z-0151-2023 Class II | EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of… | Boston Scientific Corporation | 09/30/2022Open, Classified |
| Z-0390-2022 Class II | Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN…The back of some Medical Device Identification Cards provided to patients were printed with an erroneous… | Medtronic Inc., Cardiac Rhythm and Heart… | 11/08/2021Terminated |