VAPR COOLPULSE 228146Recalls & reported problems

Summary

The FDA's MAUDE database contains 474 adverse event reports that list this exact device (DI 10886705010080), received between Mar 28, 2018 and Sep 30, 2026 — classified as 12 injuries, 462 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (184 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 474 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950035 ↗
• MalfunctionSep 14, 2026Detachment of Device or Device Component

  It was reported that during an unknown procedure, it was discovered that the metal piece on the VAPR COOLPULSE90 ELECTRODE device fell off. It was not reported if there were any delays to the surgical procedure. It was reported that a spare device was used to complete the surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757421 ↗
• MalfunctionAug 25, 2026Device Damaged Prior to Receipt by User

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438725 ↗
• MalfunctionAug 25, 2026Device Damaged Prior to Receipt by User

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438724 ↗
• MalfunctionAug 25, 2026Overheating of Device

  It was reported that during an unspecified surgery, it was noted that the tip of the VAPR COOLPULSE was charred. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50427187 ↗
• MalfunctionAug 20, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351257 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE VAPR COOLPULSE90 ELECTRODE DEVICE METAL HEAD FELL OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008748 ↗
• MalfunctionApr 10, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT THE VAPR COOLPULSE90 ELECTRODE DEVICE WAS NON-FUNCTIONAL FROM INITIAL USE. LIQUID DID NOT TRANSFER TO THE SECTION BUCKET AS INTENDED, CREATING A POTENTIAL RISK OF TISSUE OVERHEATING. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839129 ↗
• MalfunctionApr 3, 2026Infusion or Flow Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VAPR COOLPULSE90 ELECTRODE DEVICE STOPPED SUCTIONING SUDDENLY. THERE WERE NO REPORTS OF DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775888 ↗
• MalfunctionApr 2, 2026Display or Visual Feedback Problem; Use of Device Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A REDUCTION AND INTERNAL FIXATION OF INTERCONDYLAR EMINENCE FRACTURE OF LEFT KNEE JOINT, THE VAPR COOLPULSE GOT JAMMED AND DID NOT WORK. INDISTINCT VISION DURING THE PROCEDURE WAS INTERFERING WITH THE SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THE PATIENT. NO ADDITIONAL INFORMATION HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766728 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER ARTHROSCOPIC EXPLORATION AND CLEANING+JOINT RELEASE+ACROMIOPLASTY+ROTATOR CUFF REPAIR+BICEPS TENDON FIXATION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VAPR COOLPULSE DEVICE COMPONENT WAS DETACHED. WHEN USING RADIOFREQUENCY, THE ELECTRODE PAD AT THE HEAD END FELL OFF, WITH A DEFECT OF ABOUT 2*2MM. A LARGE AMOUNT OF PHYSIOLOGICAL FLUSHING WAS GIVEN, AND C-ARM MACHINE IMAGING WAS USED TO CONFIRM THAT THERE WERE NO FOREIGN OBJECTS LEFT. THERE WERE NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690957 ↗
• MalfunctionMar 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE METAL TIP OF THE ACTIVE VAPR COOLPULSE90 ELECTRODE DEVICE FELL OFF DURING OPERATION AND HAD TO BE REMOVED ARTHROSCOPICALLY. IT WAS REPORTED THAT THERE WAS A SURGICAL DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675994 ↗
• MalfunctionMar 19, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE VAPR COOLPULSE90 ELECTRODE DEVICE GOT JAMMED AND DID NOT WORKED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644372 ↗
• MalfunctionMar 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE VAPR COOLPULSE90 ELECTRODE DEVICE ELECTRODE PAD AT THE FRONT END OF THE BLADE FELL OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642475 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE THAT THE VAPR COOLPULSE90 ELECTRODE DEVICE HAD A METAL PIECE FALL OFF WITHIN THE PATIENT. THE PIECE WAS SUCCESSFULLY REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523706 ↗
• MalfunctionFeb 17, 2026Degraded; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE VAPR COOLPULSE90 ELECTRODE DEVICE COULD NOT CUT AND COAGULATE. IT WAS FURTHER OBSERVED THAT THERE WAS RUST FOUND AT THE TOP OF THE DEVICE. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367098 ↗
• MalfunctionFeb 10, 2026Output Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VAPR COOLPULSE90 ELECTRODE DEVICE WAS WORKING INTERMITTENTLY. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309676 ↗
• MalfunctionFeb 9, 2026Output Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE VAPR COOLPULSE90 ELECTRODE DEVICE WORKED INTERMITTENTLY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293154 ↗
• MalfunctionFeb 9, 2026Output Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE VAPR COOLPULSE90 ELECTRODE DEVICE WORKED INTERMITTENTLY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293106 ↗
• MalfunctionFeb 9, 2026Output Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE VAPR COOLPULSE90 ELECTRODE DEVICE WORKED INTERMITTENTLY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293091 ↗
• MalfunctionJan 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE PLATE OF THE VAPR COOLPULSE90 ELECTRODE DEVICE DETACHED AND REMAINED IN THE PATIENT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24080803 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT DURING AN ELBOW JOINT STIFFNESS RELEASE PROCEDURE, METAL SHAVINGS FROM THE PLASMA BLADE OF THE VAPR COOLPULSE90 ELECTRODE DEVICE FELL OFF. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021105 ↗
• MalfunctionJan 6, 2026Material Discolored; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO A ROTATOR CUFF REPAIR PROCEDURE, THE VAPR COOLPULSE90 ELECTRODE DEVICE WAS FOUND TO BE YELLOW AND DIRTY. CHANGED TO ANOTHER VAPR COOLPULSE90 ELECTRODE DEVICE AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972735 ↗
• MalfunctionJan 6, 2026Material Discolored; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO A ROTATOR CUFF REPAIR PROCEDURE, THE VAPR COOLPULSE90 ELECTRODE DEVICE WAS FOUND TO BE YELLOW AND DIRTY. CHANGED TO ANOTHER VAPR COOLPULSE90 ELECTRODE DEVICE AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972733 ↗
• MalfunctionDec 22, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE TWO (X2) VAPR COOLPULSE90 ELECTRODE DEVICES JAMMED AND HAD NO FORCE OR SUCTION. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED THE THIRD DEVICE, AFTER CONNECT WITH GENERATOR, DOES NOT FUNCTION AT ALL, THE SCREEN DID NOT SHOW ANY ALERT CODE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863316 ↗