SoloPace EPG SOLOEPG1Recalls & reported problems
Solo Pace Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850056280020), received between Apr 2, 2026 and Apr 2, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Over-Sensing4
- Under-Sensing2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Over-Sensing
CUSTOMER REPORTS THEY HAVE A COMPLAINT ABOUT R ON T PACING IN BACKUP PACING MODE POST VALVE DELIVERY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766968 ↗MalfunctionApr 2, 2026Over-Sensing
THE EPG WAS OVERSENSING AFTER CAPTURE CHECK. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766967 ↗MalfunctionApr 2, 2026Under-Sensing
CUSTOMER REPORTS SOLOPACE GENERATOR HAD UNDER SENSING CONSISTENTLY AFTER ANY RAPID PACING SEQUENCE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766966 ↗MalfunctionApr 2, 2026Over-Sensing
EPG OVERSENSING USING THE PACEL LEAD. THE OVERSENSING WENT AWAY WHEN THE AC POWER WAS DISCONNECTED (THE EPG WAS ON BATTERY BACKUP). THE OVERSENSING ALSO WENT AWAY AFTER RAPID PACING WAS INITIATED AND STOPPED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766965 ↗MalfunctionApr 2, 2026Over-Sensing; Under-Sensing
CUSTOMER REPORTS THE CAPTURE CHECK DOESN'T WORK ON THE FIRST OR SECOND TRY WITH ABBOTT PACEL LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766959 ↗
Other Pulse-Generator, Pacemaker, External devices
- NA 5392Medtronic, Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL1 death1,934 reports
- NA 5392Medtronic, Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL2 deaths930 reports
- NA 5392Medtronic, Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL2 deaths654 reports
- NA 5392Medtronic, Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL504 reports
- NA 53401Medtronic, Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL133 reports
- Solo Pace Control System SOLOEPG1LSolo Pace Inc. · Pulse-Generator, Pacemaker, External5 reports
- PRO PADZ 8900-4006Zoll Medical Corporation · PULSE-GENERATOR, PACEMAKER, EXTERNAL3 reports
- 5391Oscor Inc. · PULSE-GENERATOR, PACEMAKER, EXTERNAL1 death2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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