Solo Pace Control System SOLOEPG1LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850056280037), received between Apr 2, 2026 and Apr 3, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Loose or Intermittent Connection

  CUSTOMER REPORTS THE DEVICE IS HAVING ISSUES PACING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778655 ↗
• MalfunctionApr 2, 2026Over-Sensing; Under-Sensing

  THE EPG FUNCTIONED AS DESIGNED IN VOO MODE DURING RAPID PACING AND 2 HEART VALVES WERE SUCCESSFULLY DEPLOYED. THE CONTINUITY TEST LIGHT INDICATOR GAVE A FALSE INDICATION THAT LEAD WIRE CONTINUITY WAS NOT INTACT, WHEN IN FACT THE CONTINUITY WAS INTACT AND THE SYSTEM WAS ABLE TO DELIVER APPROPRIATE CURRENT TO THE HEART AND PACE. IN ADDITION, THE EPG SENSING FUNCTION IN VVI MODE DID NOT FUNCTION AS DESIGNED. THERE WERE TIMES WHERE THERE WAS VENTRICULAR UNDERSENSING, AND ALSO TIMES WHERE THERE WAS VENTRICULAR OVERSENSING LEADING TO IRREGULARITIES IN PACING OUTPUT TIMING. THESE WERE ALL PRESENT AT LOW PACING RATES, AND IN NO CASE CAUSED AN ARRHYTHMIA OR HEMODYNAMIC INSTABILITY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766963 ↗
• MalfunctionApr 2, 2026Over-Sensing

  THE EPG FUNCTIONED AS DESIGNED IN VOO MODE DURING RAPID PACING AND THE HEART VALVE WAS SUCCESSFULLY DEPLOYED. THE EPG WAS OVER-SENSING WHEN IN VVI MODE DURING CAPTURE CHECK. THE OVER-SENSING OCCURRED BOTH AT 3MA AND 25MA PACING OUTPUTS. THE OVER-SENSING DID NOT CAUSE ARRHYTHMIAS OR HEMODYNAMIC INSTABILITY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766962 ↗
• MalfunctionApr 2, 2026Over-Sensing; Under-Sensing

  THE EPG FUNCTIONED AS DESIGNED IN VOO MODE DURING RAPID PACING AND 2 HEART VALVES WERE SUCCESSFULLY DEPLOYED. THE CONTINUITY TEST LIGHT INDICATOR GAVE A FALSE INDICATION THAT LEAD WIRE CONTINUITY WAS NOT INTACT, WHEN IN FACT THE CONTINUITY WAS INTACT AND THE SYSTEM WAS ABLE TO DELIVER APPROPRIATE CURRENT TO THE HEART AND PACE. IN ADDITION, THE EPG SENSING FUNCTION IN VVI MODE DID NOT FUNCTION AS DESIGNED. THERE WERE TIMES WHERE THERE WAS VENTRICULAR UNDERSENSING, AND ALSO TIMES WHERE THERE WAS VENTRICULAR OVERSENSING LEADING TO IRREGULARITIES IN PACING OUTPUT TIMING. THESE WERE ALL PRESENT AT LOW PACING RATES, AND IN NO CASE CAUSED AN ARRHYTHMIA OR HEMODYNAMIC INSTABILITY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766961 ↗
• MalfunctionApr 2, 2026Over-Sensing; Under-Sensing

  THE EPG FUNCTIONED AS DESIGNED IN VOO MODE DURING RAPID PACING AND 2 HEART VALVES WERE SUCCESSFULLY DEPLOYED. THE CONTINUITY TEST LIGHT INDICATOR GAVE A FALSE INDICATION THAT LEAD WIRE CONTINUITY WAS NOT INTACT, WHEN IN FACT THE CONTINUITY WAS INTACT AND THE SYSTEM WAS ABLE TO DELIVER APPROPRIATE CURRENT TO THE HEART AND PACE. IN ADDITION, THE EPG SENSING FUNCTION IN VVI MODE DID NOT FUNCTION AS DESIGNED. THERE WERE TIMES WHERE THERE WAS VENTRICULAR UNDERSENSING, AND ALSO TIMES WHERE THERE WAS VENTRICULAR OVERSENSING LEADING TO IRREGULARITIES IN PACING OUTPUT TIMING. THESE WERE ALL PRESENT AT LOW PACING RATES, AND IN NO CASE CAUSED AN ARRHYTHMIA OR HEMODYNAMIC INSTABILITY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766960 ↗