VersaPulse P20Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07290109140544), received between Jan 22, 2019 and Mar 23, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (12 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Nonstandard Device; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CONSOLE GOT FROZE IN THE MIDDLE OF THE CASE AND THE MEDICAL STAFF ACCIDENTLY PRESSED E-STOP BUTTON; THEN THE DEVICE TURNED OFF AND RELEASED THE E-STOP BUTTON, KEY SWITCH ON, TURN ON THE LASER, AND FINALLY, THE ERROR 24 (EMERGENCY STOP BUTTON FAULT-EMERGENCY STOP NOTIFICATION (FOR SERVICE)) WAS DISPLAYED. THE ERROR PERSISTED AFTER MULTIPLES TIMES TO RESTART. DUE TO THIS, THE PROCEDURE HAD TO BE CANCELLED. 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 24671556 ↗
• MalfunctionSep 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE FOOTSWITCH WAS STUCK IN ON POSITION AND CONSTANTLY SHOOTING. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089919 ↗
• MalfunctionMay 27, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE LASER CONTINUES FIRING EVEN AFTER THE FOOT SWITCH IS RELEASED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091163 ↗
• MalfunctionApr 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER THE FIBER WAS CONNECTED TO THE CONSOLE, THE CONSOLE WAS ABLE TO BE USED FOR A WHILE. HOWEVER, AFTER BEING USED FOR A WHILE, THERE WAS A SPARK AT THE CONSOLES CONNECTOR. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858050 ↗
• MalfunctionFeb 27, 2025Device Displays Incorrect Message; Communication or Transmission Problem; Device Displays Incorrect Message; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A URETEROSCOPY BILATERAL PROCEDURE, THE CONSOLE DISPLAYED ERROR CODE 20 FLASHLAMP IGNITION FAILURE. THE CONSOLE WAS RESTARTED, BUT THE ERROR STILL POPS UP ON THE SCREEN. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT. 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 21485363 ↗
• MalfunctionJan 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT, THE EMERGENCY STOP BUTTON WAS COMING LOOSE FROM THE CONSOLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233637 ↗
• MalfunctionDec 4, 2024Defective Device; Device Displays Incorrect Message; Output below Specifications; Defective Device; Device Displays Incorrect Message; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE DID NOT DETECT THE FIBER. IN ADDITION, THE CONSOLE DISPLAYER ERROR CODE 73 - CASE SAVER MODE CANNOT FINISH PROCEDURE - DOWNGRADE CASE SAVER MODE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT INVOLVEMENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846372 ↗
• MalfunctionFeb 1, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS AN ERROR MESSAGE DISPLAYED AND DUE TO THIS, THE PROCEDURE WAS CANCELLED. NO PATIENT OUTCOME WAS REPORTED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623976 ↗
• MalfunctionDec 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A LOUD POPPING SOUND WAS HEARD, FLAMES SHOT OUT THE BACK OF THE CONSOLE AND THEN IT SHUT DOWN ON ITS OWN. THE CONSOLE WAS UNPLUGGED AND PLACED OUT OF SERVICE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18269689 ↗
• MalfunctionSep 14, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT ERROR 67 OCCURRED PRIOR TO THE URETEROSCOPIC LITHOTRIPSY (URSL) STONE REMOVAL PROCEDURE STARTING. TWO DIFFERENT FIBERS WERE ATTEMPTED TO BE USED WITH THE CONSOLE. HOWEVER, THE PROCEDURE WAS THEN CANCELLED DUE TO THE ERROR RECEIVED STATING THE FIBER EXPIRED. THE CUSTOMER WOULD NOT PROVIDE INFORMATION REGARDING WHETHER THERE WERE ANY PATIENT COMPLICATIONS OR WHETHER THE PATIENT WAS SEDATED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746422 ↗
• MalfunctionDec 30, 2021Failure to Deliver Energy; Failure to Deliver Energy

  LUMENIS RECEIVED A FOREIGN USER FACILITY SUBMITTED CMDSNET REPORT ((B)(4)) ON 7-DEC-2021 REGARDING AN EVENT THAT ALLEGEDLY HAPPENED ON THE (B)(6) 2021. DURING A LASER LITHOTRIPSY AND STENT EXCHANGE PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 20W LASER SYSTEM WAS BEING UTILIZED, ERROR MESSAGE APPEARED ON THE SCREEN "SERVICE REQUIRED". UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. 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 13116238 ↗
• MalfunctionJul 29, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A LITHOTRIPSY PROCEDURE, IN WHICH A LUMENIS VERSAPULSE P20 LASER SYSTEM WAS BEING UTILIZED, THE LASER PRESENTED FOOTSWITCH ERROR MESSAGE. THE PHYSICIAN STATED THAT CONNECTOR APPEARED DAMAGED. UNABLE TO PROCEED WITH THE LASER, THE PROCEDURE WAS CANCELED. 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 12243702 ↗
• MalfunctionJul 8, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A STONE PROCEDURE IN WHICH A LUMENIS VERSAPULSE P20 LASER SYSTEM WAS TO BE UTILIZED, ERROR MESSAGE APPEARED ON THE SCREEN. UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. 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. THE PROCEDURE WAS COMPLETED AT ANOTHER DAY WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135312 ↗
• MalfunctionJul 5, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A FOREIGN USER FACILITY REPORTED THAT PRIOR TO BEGINNING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE P20 LASER SYSTEM WAS TO BE UTILIZED, THE LASER WOULD NOT START UP AND FAILED DURING THE SELF TEST. UNABLE TO BEGIN THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. 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 12114830 ↗
• MalfunctionApr 21, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE P20 LASER WAS BEING UTILIZED, THE SYSTEM DISPLAYED ERROR 27 AND THEY WERE NOT ABLE TO CLEAR THE ERROR BY RESTARTING THE SYSTEM. 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 11699311 ↗
• MalfunctionMar 15, 2021Failure to Deliver Energy; Failure to Deliver Energy

  ACCORDING TO (B)(4) REPORT NUMBER, (B)(4). A FOREIGN A USER FACILITY REPORTED THAT DURING A PROCEDURE, IN WHICH A LUMENIS VERSAPULSE P20 LASER SYSTEM WAS BEING UTILIZED, THE FOOTSWITCH OF THE SYSTEM ALLEGEDLY FAILED AND THE SYSTEM WAS UNABLE TO FIRE. UNABLE TO PROCEED WITH THE LASER, THE PROCEDURE WAS CANCELED. 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 11480893 ↗
• MalfunctionJan 12, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A LITHOTRIPSY PROCEDURE, IN WHICH A LUMENIS VERSAPULSE P20 LASER SYSTEM WAS BEING UTILIZED, THE FOOTSWITCH OF THE SYSTEM FAILED AND THE SYSTEM WAS UNABLE TO FIRE. UNABLE TO PROCEED WITH THE LASER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11153309 ↗
• MalfunctionOct 6, 2020Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A RENAL CALCULAI PROCEDURE IN WHICH A LUMENIS VERSAPULSE P20 LASER WAS BEING UTILIZED, THE DISPLAY PRESENTED ERROR AND THE LASER COULD NO LONGER BE USED. UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. 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 10633820 ↗
• MalfunctionAug 3, 2020Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE P20 LASER SYSTEM WAS BEING UTILIZED, THE FOOTSWITCH OF THE SYSTEM FAILED AND THE SYSTEM WAS UNABLE TO FIRE. THE PROCEDURE WAS COMPLETED USING A LUMENIS VERSAPULSE P80/100 LASER INSTEAD. 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 10354530 ↗
• MalfunctionApr 1, 2020Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A CYSTOLITHOTRIPSY PROCEDURE IN WHICH A LUMENIS PULSE 20H WAS BEING UTILIZED, THE SYSTEM STOPPED WORKING. THE PHYSICIAN TRIED A BASKET REMOVAL AND WAS UNSUCCESSFUL. THEY ENDED UP PUTTING IN A STENT. UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. 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 9909541 ↗
• MalfunctionMar 23, 2020Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING AN URETEROSCOPY WITH STONE EXTRACTION PROCEDURE IN WHICH A LUMENIS VERSAPULSE 20 W LASER WAS BEING UTILIZED, FIBER NOT CONNECTED ERROR APPEARED ON THE SCREEN. UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. 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 9864316 ↗
• MalfunctionMay 20, 2019Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS VERSAPULSE P20 LASER WAS BEING UTILIZED, THE LASER WOULD NOT FIRE. DESPITE TRYING SEVERAL FIBERS, THE SYSTEM WOULD NOT FIRE. UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND RESCHEDULED. 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 8622857 ↗
• MalfunctionJan 22, 2019Activation Problem; Activation Problem

  LUMENIS WAS INFORMED BY A FOREIGN DISTRIBUTOR THAT A FOREIGN USER FACILITY REPORTED THAT PRIOR TO THE START OF A URETEROSCOPY PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE P20 LASER WAS TO BE UTILIZED, THE OPERATOR WAS UNABLE TO START THE LASER BY TURNING THE KEY SWITCH. AN ALTERNATE LASER, A LUMENIS PULSE 100 WAS THEN BROUGHT IN TO THE ROOM TO CONTINUE THE PROCEDURE. IMMEDIATELY AFTER TURNING ON THE P100 LASER, A LOUD NOISE WAS OBSERVED AND THE LASER SUBSEQUENTLY TURNED OFF, LEAVING THE LASER INOPERABLE. AS THERE WAS NO OTHER ALTERNATE DEVICE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM ANESTHESIA. NO REPORT OF INJURY WAS RECEIVED, NOR DID THE MALFUNCTION CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S STATUS. THIS IS FOR DEVICE 1 OR 2 (LUMENIS VERSAPULSE POWERSUITE P20).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8266335 ↗