VersaPulse PowerSuite 30WRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07290109140568), received between Oct 3, 2021 and Jun 26, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CONSOLE SHOWED A LOW POWER MESSAGE AND RETURNED TO STANDBY MODE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341521 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PRESENTED AT THE 112TH ANNUAL MEETING OF THE JAPANESE UROLOGICAL ASSOCIATION THAT A RETROSPECTIVE EVALUATION WAS CONDUCTED TO EVALUATE THE SURGICAL OUTCOMES OF TRANSURETHRAL LITHOTRIPSY (TUL) AT THE TODACHUO GENERAL HOSPITAL. A TOTAL OF 86 PATIENTS WITH A MEDIAN AGE OF 58 YEARS (RANGE, 16-87 YEARS) WHO UNDERWENT TUL BETWEEN APRIL 2023 AND JUNE 2024 WERE EVALUATED. THE PARTICIPANTS INCLUDED 57 MALES AND 29 FEMALES. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED PREOPERATIVELY TO PATIENTS WITH POSITIVE URINE CULTURES OR THOSE AT HIGH RISK OF INFECTION. THE TARGET STONES WERE LOCATED ON THE RIGHT SIDE, LEFT SIDE, OR IN A TRANSPLANTED KIDNEY. PRE-STENTING WAS PERFORMED IN 36 CASES, WITH 25 CASES DUE TO STONE-INDUCED PYELONEPHRITIS, AND 4 DUE TO DIFFICULT URETERS FROM PRIOR SURGERIES. THE MEDIAN LONGEST DIAMETER OF THE STONES WAS 8 MM (RANGE, 3-17 MM), AND THE MEDIAN SHORTEST DIAMETER WAS 6.5 MM (RANGE, 2-16 MM). THERE WERE 29 RIGID-TUL CASES AND 57 FLEXIBLE-TUL CASES. THE MEDIAN SURGICAL TIME WAS 68 MINUTES (RANGE, 20-159 MINUTES). THE STONE-FREE RATE WAS 90.6 %. PERIOPERATIVE COMPLICATIONS INCLUDED URETERAL INJURY IN 9 CASES, POSTOPERATI

  Patient problems: Septic Shock; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22006475 ↗
• MalfunctionMar 12, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE'S BLAST SHIELD WAS BURNOUT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21589887 ↗
• MalfunctionFeb 5, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN OBSERVED THAT THE CONSOLE SCREEN SHOWED HERTZ (HZ) INCREASING BUT THE IRRADIATION REMAINED AT 5HZ. THERE WAS NO COURTESY MESSAGES DISPLAYED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE CONSOLE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315420 ↗
• MalfunctionJan 22, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT AT THE BEGINNING OF THE PROCEDURE, WHEN THE FIBER WAS INSERTED ALL THE WAY, THE POWER TO THE MAIN UNIT TURNED OFF. THE FIBER WAS REPLACED AND THE LASER WAS RESTARTED BUT THE SAME ISSUE PERSISTED. THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS ALREADY SEDATED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH OR UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21212246 ↗
• MalfunctionSep 17, 2024Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, WHEN THIS CONSOLE WAS STARTED, ERROR CODE 703 APPEARED, AND IT COULD NO LONGER BE USED. THE PROCEDURE WAS CANCELLED DUE TO THIS ERROR. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED DUE TO THE PROCEDURE BEING ABORTED POST THE ADMINISTRATION OF SEDATION/SEDATION ADMINISTRATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242372 ↗
• MalfunctionAug 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS WATER LEAKAGE FROM MAIN UNIT DEVICE. DUE TO THIS, THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. 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 19924042 ↗
• MalfunctionOct 30, 2023Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT THE CONSOLE SHUT DOWN IMMEDIATELY AFTER TURNING IT ON. THE PROCEDURE HAD TO BE CANCELLED DUE TO THE MALFUNCTION. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029796 ↗
• MalfunctionJul 25, 2023Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE OUTPUT OF THE CONSOLE BEGAN TO EXHIBIT LIMITATIONS SIMILAR TO CASE SAVER MODE. THE PROCEDURE WAS POSTPONED. 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 17393705 ↗
• MalfunctionOct 3, 2022Smoking; Smoking

  IT WAS REPORTED THAT THERE WAS SMOKE COMING OUT OF THE PROBE OF THE CONSOLE. AFTER RESTARTING THE POWER SUPPLY THREE TIMES, IT WAS ABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15533815 ↗
• InjuryMay 4, 2022Break; Break

  A FOREIGN USER FACILITY REPORTED THAT AT THE END OF A TUL PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 30 LASER WAS BEING UTILIZED WITH A LUMENIS SLIMLINE 200 FIBER, THE PHYSICIAN NOTICED THAT THE AIMING BEAM DISAPPEARED. HOWEVER, THE PROCEDURE WAS CONTINUED, AND THE OPERATION WAS PERFORMED BY INCREASING THE OUTPUT OF THE LASER BEAM. A FIRE STARTED FROM THE AREA WHERE A PART OF THE FIBER WAS SET TO A LOOP AND CLIPPED TO THE PATIENT'S DRAPE WITH CLOTH FORCEPS. THE STAFF, ON THE SPOT USED SALINE TO EXTINGUISH THE FIRE ON THE DRAPE. THE PATIENT GOT A MINOR BURN AND WAS TREATED BY A DERMATOLOGIST AND DISCHARGED FROM THE HOSPITAL.

  Patient problems: Burn(s)

  MAUDE report 14275701 ↗
• MalfunctionOct 3, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A FOREIGN USER FACILITY REPORTED THAT ALMOST AT THE END OF A TUL PROCEDURE IN WHICH A LUMENIS POWERSUITE 30W LASER WAS BEING UTILIZED, ERROR MESSAGE APPEARED ON THE SCREEN AND THE SYSTEM STOPPED WORKING. UNABLE TO CONTINUE WITH THE SYSTEM AN ALTERNATE METHOD WAS USED TO COMPLETE THE PROCEDURE. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566512 ↗