VersaPulse PowerSuite 60WRecalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 07290109140575), received between Feb 19, 2019 and Sep 29, 2026 — classified as 2 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (27 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 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Output below Specifications

  It was reported that during inspection, it was found that the energy was low. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927646 ↗
• MalfunctionSep 28, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925859 ↗
• MalfunctionJul 27, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038006 ↗
• MalfunctionApr 24, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING PREPARATION, THE FRONT DOOR OF THE CONSOLE COULD NOT BE CLOSED. THERE WERE NO PROCEDURE AND PATIENT OUTCOME REPORTED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988191 ↗
• MalfunctionApr 8, 2026Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT, DURING PREPARATION/PRIOR TO PROCEDURE, IT WAS FOUND THAT THE DEVICE HAD LOW ENERGY. THE PROCEDURE AND PATIENT OUTCOMES WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824287 ↗
• MalfunctionApr 2, 2026Failure to Power Up; Unexpected Shutdown

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, AFTER POWERING ON AND WARMING UP, THE CONSOLE SUDDENLY SHUTDOWN DUE TO POWER LOSS AND COULD NOT BE RESTARTED. THE PROCEDURE WAS POSTPONED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767745 ↗
• MalfunctionMar 23, 2026Output below Specifications

  IT WAS REPORTED THAT BEFORE THE PROCEDURE, IT WAS FOUND THAT THE DEVICE HAD LOW ENERGY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671613 ↗
• MalfunctionMar 19, 2026Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS FOUND THAT THE CONSOLE SEEMED TO HAVE A POWER REDUCTION. THE PROCEDURE WAS COMPLETED USING SAME CONSOLE. NO INFORMATION REGARDING THE PATIENT OUTCOME WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645796 ↗
• MalfunctionFeb 18, 2026Output below Specifications

  IT WAS REPORTED THAT DURING THE INSPECTION, IT WAS FOUND THAT THE CONSOLE HAD LOW ENERGY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381390 ↗
• MalfunctionFeb 16, 2026Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT DURING MAINTENANCE, FOUND THAT THE ENERGY WAS 70% OF THE NORMAL VALUE, THERE WERE BAD POINTS IN THE FIRST LASER ROD, THE LOW END OF THE FOURTH CHANNEL WAS 51 AND THE ENERGY OF THE THIRD LASER CAVITY WAS LOW. THERE WERE NO PATIENT OR PROCEDURE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24354984 ↗
• MalfunctionFeb 11, 2026Output below Specifications

  IT WAS REPORTED THAT DURING THE INSPECTION, IT WAS FOUND THAT THE DEVICE HAD POWER LOSS OCCASIONALLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311007 ↗
• MalfunctionFeb 9, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS FOUND THAT THE CONSOLE ALERTED ERROR CODE 201 - SHUTTER TEST FAILED WHEN TURNED ON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WAS NO PATIENT COMPLICATION. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290501 ↗
• MalfunctionJan 8, 2026Output below Specifications

  IT WAS REPORTED THAT PRIOR TO PROCEDURE, FOUND THAT THE ENERGY LEVEL OF THIS DEVICE WAS LOW. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24009380 ↗
• MalfunctionDec 27, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE DEVICE HAD LOW ENERGY DURING DAILY INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901380 ↗
• MalfunctionDec 19, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT AFTER THE PROCEDURE, IT WAS FOUND THAT THE ENERGY WAS LOW. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853518 ↗
• MalfunctionDec 4, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS FOUND THAT THE ENERGY WAS LOW. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713187 ↗
• MalfunctionNov 12, 2025Nonstandard Device; Output below Specifications; Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE USER FEELS THAT THE ENERGY OUTPUT HAD DECREASED COMPARED TO BEFORE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537112 ↗
• MalfunctionOct 20, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT BEFORE A PROCEDURE, WAS FOUND THAT THE DEVICE HAD LOW ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337173 ↗
• MalfunctionOct 15, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, WAS FOUND THAT THE DEVICE COULD NOT IDENTIFY THE PADEL. THE PATIENT WAS SEDATED UNDER GENERAL ANESTHESIA, AND THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE CASE WAS NOT COMPLETED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299890 ↗
• MalfunctionOct 3, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING PREPARATION FOR PROCEDURE, THE CONSOLE HAD LOW ENERGY. THE PROCEDURE WAS COMPLETED USING ANOTHER CONSOLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23209889 ↗
• MalfunctionAug 28, 2025Adverse Event Without Identified Device or Use Problem; Output below Specifications; Adverse Event Without Identified Device or Use Problem; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN FOUND AN ENERGY LIMIT WITH THE CONSOLE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE WITHOUT PATIENT COMPLICATIONS. THE CONSOLE DID NOT DISPLAY CASE SERVER MODE OR ERROR CODES; HOWEVER THE USER FEELS THAT THE ENERGY OUTPUT HAS DECREASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919130 ↗
• MalfunctionJul 30, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING THE USE OF THE DEVICE, THE LASER OUTPUT WAS INSUFFICIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669250 ↗
• MalfunctionJul 15, 2025Smoking; Smoking

  IT WAS REPORTED THAT THERE WERE SOUNDS OF FIRECRACKERS AND A SMELL OF BURNING DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508429 ↗
• MalfunctionJun 9, 2025Defective Device; Material Integrity Problem; Output below Specifications; Defective Device; Material Integrity Problem; Output below Specifications

  IT WAS REPORTED THAT DURING PROCEDURE, IT WAS FOUND THAT THE DEBRIS SHIELD WAS DAMAGED. IN ADDITION, THE OUTPUT POWER WAS LOW. IT WAS SUSPECTED THAT THE DAMAGE TO THE FOCUSING LENS WAS CAUSED BY THE USER'S ACTIVATION AFTER THE DEBRIS SHIELD WAS DAMAGED. IT WAS REQUIRED TO CLEAN THE PORT, CHECK AND CALIBRATE THE OPTICAL PATH, CHECK, CLEAN OR REPLACE THE FOCUS LENS, AND CALIBRATE THE POWER. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166637 ↗
• MalfunctionMay 14, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE DEVICE HAD LOW ENERGY DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022856 ↗