VersaPulse PowerSuite 80/100WRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07290109140582), received between Feb 25, 2019 and Feb 27, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS FOUND THAT THE ENERGY LEVEL WAS LOW, WITH THE MAXIMUM BEING 20W. ADDITIONAL INFORMATION WAS RECEIVED AT A LATER TIME, REPORTING THAT THIS CONSOLE WAS UNDER CASE SAVER MODE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474517 ↗
• MalfunctionAug 20, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT POST PROCEDURE, THE PHYSICIAN FOUND THAT THE UNIT HAD LOW POWER. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WAS NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846965 ↗
• MalfunctionMay 30, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE'S POWER COULD NOT BE INCREASED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120008 ↗
• MalfunctionFeb 11, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT CONSOLE IS NEARING ITS END OF LIFE, AND IT IS NOW OPERATING WITH REDUCED OUTPUT AT 80% EFFICIENCY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OR PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358479 ↗
• MalfunctionJan 10, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE ENERGY OF THE MACHINE WAS LOW. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITHOUT PATIENT COMPLICATIONS. FURTHER INFORMATION RECEIVED FROM THE FACILITY INDICATED THAT THE PHYSICIAN WAS AWARE OF THE LOW ENERGY AS THE CONSOLE DISPLAYED THE MESSAGE ON THE CONSOLE SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21127216 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE INTERNATIONAL BRAZILIAN JOURNAL OF UROLOGY THAT A STUDY WAS CONDUCTED TO ASSESS THE EFFICACY AND SAFETY OF HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) IN PATIENTS WITH HIGH COMORBIDITY BURDEN. A TOTAL OF OUT OF 305 CASES OF PATIENTS WERE STUDIED. THE FOLLOWING BOSTON SCIENTIFIC PRODUCTS WERE USED DURING THE PROCEDURES: VERSACUT MORCELLATOR, VERSAPULSE 120W AND ACCUMAX 550 LASER FIBER. ACCORDING TO THE STUDY RESULTS, 10 AND 20 PATIENTS EXPERIMENTED BLADDER MUCOSAL DAMAGE AND CAPSULE PERFORATION, RESPECTABLY AS INTRAOPERATIVE COMPLICATIONS. REGARDING POSTOPERATIVE COMPLICATIONS, FOR 10 PATIENTS A BLOOD TRANSFUSION WAS NECESSARY, 1 PATIENT EXPERIENCED POSTOPERATIVE FEVER AND IT WAS NEEDED TO REPLACE VESICAL CATHETER AND 8 PATIENTS SUFFERED ORCHIEPIDIDYMITIS (INFLAMMATION OF THE EPIDIDYMIS AND/OR TESTICLE). TWO PATIENTS DEVELOPED URINARY RETENTION AND 4 PATIENTS REQUIRED A CLOT RETENTION. URINARY INCONTINENCE AT 3 MONTHS WAS ALSO PRESENTED IN 6 PATIENTS AND 4 PATIENTS REQUIRED A REINTERVENTION FOR A URETHRAL STRICTURE.

  Patient problems: Fever; Hematuria; Hemorrhage/Blood Loss/Bleeding; Perforation; Unspecified Tissue Injury; Urethral Stenosis/Stricture; Urinary Incontinence; Urinary Retention

  MAUDE report 19525113 ↗
• MalfunctionNov 8, 2022Loss of Power; Loss of Power

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE DEVICE OUTPUT POWER WAS NOT SUFFICIENT. THERE PROCEDURE WAS CANCELLED DUE TO THIS ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. 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 15750102 ↗
• MalfunctionNov 18, 2020Break; Optical Decentration; Break; Optical Decentration

  A USER FACILITY REPORTED THAT WHILE USING A LUMENIS VERSA-PULSE POWER SUITE 80/100 LASER WITH A NON-LUMENIS FIBER DURING A BLADDER STONE LITHOTRIPSY PROCEDURE, FIBER FAILED IN THE MIDDLE, AND SHOOT A BEAM ONTO A DRAPE. THE PROCEDURE WAS SUBSEQUENTLY CANCELLED AND THE PATIENT WAS AWAKENED FROM ANESTHESIA. NO INJURIES TO PATIENT, OR USER WERE REPORTED, AND NO REPORT THAT THE MALFUNCTION CAUSED, OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10860279 ↗
• MalfunctionOct 23, 2019Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT AT THE START OF A PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 80/100W WAS BEING UTILIZED, THE LASER DISPLAYED AN ERROR MESSAGE ON THE SCREEN "ALL LASERS INOPERABLE". UNABLE TO PROCEED WITH THE USE OF THE LASER THE REMAINDER OF THE PROCEDURE WAS COMPLETED BY USE OF AN ALTERNATE DEVICE. 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 Known Impact Or Consequence To Patient

  MAUDE report 9224172 ↗
• MalfunctionFeb 25, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  A USER FACILITY REPORTED THAT DURING A LASER PROCEDURE IN WHICH A LUMENIS VERSAPULSE 80/100W LASER SYSTEM WAS BEING UTILIZED, THE FOOTSWITCH WASN'T WORKING, SPECIFICALLY THE PLUG WHERE THE FOOT PEDAL CONNECTS WAS LOOSE. A SECOND LASER WAS NEEDED TO BE BROUGHT IN 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 Known Impact Or Consequence To Patient

  MAUDE report 8365586 ↗