ProMark PMKEM1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI D716PMKEM11), received between May 18, 2023 and Mar 31, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Mechanical Problem; Device Handling Problem

  IN THIS EVENT IT IS REPORTED THAT A PROMARK ENDO MOTOR STOPS DURING USE, DEVICE RUNNING ERRATIC. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24744868 ↗
• MalfunctionMar 19, 2026Mechanical Problem

  IN THIS EVENT IT IS REPORTED THAT A PROMARK ENDO MOTOR IS NOT RUNNING CORRECTLY, SPEED OF DEVICE IS NOT NORMAL. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637468 ↗
• MalfunctionFeb 5, 2026Mechanical Problem

  IN THIS EVENT IT IS REPORTED THAT A PROMARK ENDO MOTOR STOPPED DURING USE. A CHECK MOTOR MESSAGE WAS DISPLAYED ON DEVICE. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267191 ↗
• MalfunctionNov 13, 2024Mechanical Problem; Mechanical Problem

  IN THIS EVENT IT IS REPORTED A ASEPTICO PROMARK ENDO MOTOR WAS RUNNING SLOW AND ERRATIC DURING USE. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677639 ↗
• MalfunctionJul 23, 2024Mechanical Problem; Mechanical Problem

  IN THIS EVENT IT IS REPORTED THAT A PROMARK ENDO MOTOR UNIT NOT SPINNING CORRECTLY - HAVING MECHANICAL ISSUE. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805651 ↗
• MalfunctionMay 2, 2024Mechanical Problem; Mechanical Problem

  IN THIS EVENT IT IS REPORTED THAT PROMARK ENDO MOTOR NOT RUNNING CORRECTLY, SLOW ON ALL SETTINGS. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231043 ↗
• MalfunctionJan 2, 2024Mechanical Problem; Mechanical Problem

  IN THIS EVENT IT IS REPORTED THAT PROMARK ENDO MOTOR WAS SLOWING DURING USE - SPEED INCONSISTENT - AND VIBRATED. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425715 ↗
• MalfunctionNov 20, 2023Unintended Electrical Shock; Unintended Electrical Shock

  IN THIS EVENT IT IS REPORTED THAT DURING TREATMENT CUSTOMER WAS USING PROMARK ENDO MOTOR, THE CUSTOMER INDICATED THAT THE PATIENT JUMPED WHEN THE ROTARY FILE ENTERED BOTH THE CANALS IN TOOTH NUMBER 13. DR FINISHED THE PROCEDURE WITH HAND FILES, AND OBTURATED WITH NO COMPLICATIONS. DR SUSPECTS IT COULD HAVE BEEN A SHOCK, AS THERE WERE NO ISSUES WHEN HAND FILING, NO ROOT TISSUE TO CAUSE THE PAIN. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170910 ↗
• MalfunctionMay 18, 2023Mechanical Problem; Mechanical Problem

  IN THIS EVENT IT IS REPORTED THAT PROMARK ENDO MOTOR WAS RUNNING SLOW; HAVING MECHANICAL ISSUE. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956257 ↗