Permanent Defibrillator Electrodes
FDA adverse event reports and recall history for permanent defibrillator electrodes (product code NVY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 136,780
- Deaths
- 3,076
- Injuries
- 77,267
- Malfunctions
- 56,335
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-08-20Open, ClassifiedComponent design/selection
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
- 2025-08-20Open, ClassifiedComponent design/selection
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
- 2022-10-31Open, ClassifiedUnder Investigation by firm
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 battery capacity.
- 2022-10-31Open, ClassifiedUnder Investigation by firm
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 battery capacity.
- TerminatedError in labeling
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
Monitor permanent defibrillator electrodes automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.