VAPR 227204Recalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 10886705009626), received between Mar 22, 2018 and Aug 12, 2026 — classified as 7 injuries, 157 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (48 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 164 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227182 ↗
• MalfunctionAug 12, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227178 ↗
• MalfunctionAug 12, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221923 ↗
• MalfunctionAug 5, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146532 ↗
• MalfunctionAug 4, 2026Infusion or Flow Problem

  It was reported that during a Shoulder Arthroscopic procedure, it was discovered that the suction on the VAPR PREMIERE 90 ELECTRODE device did not work right after the surgery started. The suction equipment did not have any problem. There were no delays in the surgical procedure as 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 50132118 ↗
• MalfunctionMar 26, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE VAPR PREMIERE 90 ELECTRODE DEVICE GENERATED SPARKS. 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 24705146 ↗
• MalfunctionMar 9, 2026Overheating of Device

  IT WAS REPORTED THAT SEVEN DAYS AFTER A SHOULDER ARTHROSCOPY SURGICAL PROCEDURE USING THE VAPR PREMIERE 90 ELECTRODE -EA DEVICE, THE PATIENT WENT TO THE DOCTOR TO REMOVE THE OCCLUSIVE DRESSING AND IT WAS NOTICED THAT THE SKIN AT THE SURGICAL SITE WAS BURNED; SUFFERED SKIN DAMAGE ON THE RIGHT SHOULDER (BURNS). ACCORDING TO INFORMATION COLLECTED FROM THE INSTRUMENTATORS AT THE END OF THE SURGERY, NO LESION/BURNS WERE FOUND ON THE SKIN IN THE PATIENT (EXCEPT FOR SURGICAL INCISIONS). THE PATIENT DID NOT PROLONG THE HOSPITALIZATION, BUT HAD TO TAKE CARE OF THE BURN INJURIES AT HOME WITH MEDICAL ADVICE, PROLONGING THE HEALING FOR LONGER THAN NECESSARY. THERE WAS MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF THE EVENT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 24547211 ↗
• MalfunctionMar 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A FRAGMENT OF THE VAPR PREMIERE 90 ELECTRODE -EA DEVICE CAME LOOSE DURING AN ARTHROSCOPIC TREATMENT OF SHOULDER. THE FRAGMENT WAS LOCATED AND REMOVED. THE X-RAY EXAMINATION SHOWED AREA WAS CLEARED OF FOREIGN OBJECTS. 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 24532607 ↗
• MalfunctionMar 2, 2026Electrical /Electronic Property Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE VAPR PREMIERE 90 ELECTRODE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS UNABLE TO ABLATE. 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 24485206 ↗
• MalfunctionJan 28, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE VAPR PREMIERE 90 ELECTRODE DEVICE GENERATED SPARKS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200625 ↗
• MalfunctionJan 28, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE VAPR PREMIERE 90 ELECTRODE DEVICE GENERATED SPARKS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200603 ↗
• MalfunctionJan 20, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A SOFT TISSUE REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VAPR PREMIERE 90 ELECTRODE -EA DEVICE WAS JAMMED AND COULD NOT SUCTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 24116962 ↗
• MalfunctionDec 15, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE 5.5 HEALIX ADVANCE BR W/OCORD ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS FOREIGN MATTER OBSERVED ON THE VAPR PREMIERE 90 ELECTRODE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23806048 ↗
• MalfunctionDec 9, 2025Degraded; Device Contaminated During Manufacture or Shipping; Degraded; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE VAPR PREMIERE 90 ELECTRODE -EA DEVICE WAS NOTED TO HAVE RUST WHILE IN THE PACKAGE. ANOTHER 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 23759416 ↗
• MalfunctionNov 20, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE VAPR PREMIERE 90 ELECTRODE -EA DEVICE, THE SURGEON WENT TO USE THE WAND AND UPON THE VERY FIRST TIME USING THE WAND TO OBLATE TISSUE IT CLOGGED IMMEDIATELY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS 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 23606438 ↗
• MalfunctionNov 19, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS NOTED THAT FOREIGN MATTER WAS PRESENT ON TIP OF THE VAPR PREMIERE 90 ELECTRODE DEVICE. 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 23597938 ↗
• MalfunctionNov 3, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VAPR PREMIERE 90 ELECTRODE DEVICE WOULD NOT COAGULATE. 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 23445218 ↗
• MalfunctionOct 30, 2025Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT AFTER CONNECTION OF THE VAPR PREMIERE 90 ELECTRODE DEVICE WITH THE GENERATOR, IT DID NOT FUNCTION AT ALL AND THE SCREEN DID NOT SHOW ANY ALERT CODE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD INTERMITTENT OPERATION. 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 23423013 ↗
• MalfunctionSep 12, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT FOLLOWING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE USING THE VAPR PREMIERE 90 ELECTRODE DEVICE, MILD BURN-LIKE SYMPTOMS WERE OBSERVED NEAR THE KNEE UPON WOUND CLOSURE, MEASURING APPROXIMATELY 5 CM SQUARE. IT WAS SUSPECTED THAT THE BURNS WERE CAUSED BY EITHER THE HOT SCOPE TOUCHING THE SKIN OR THAT PERFUSION WAS NOT FUNCTIONING PROPERLY, CAUSING THE TEMPERATURE INSIDE THE JOINT TO RISE. THE REPORTER INDICATED THAT THE RISE IN TEMPERATURE COULD HAVE CAUSED THE PERFUSION FLUID TO HEAT UP AND CONTACT THE SKIN, RESULTING IN BURNS. THE SURGEON NOTED THAT, ALTHOUGH THE DIRECT CAUSAL ROLE OF THE DEVICE WAS UNCLEAR, IT MAY HAVE CONTRIBUTED TO AN INCREASE IN JOINT TEMPERATURE DUE TO POOR CIRCULATION OF PERFUSION. IT WAS REPORTED THAT THE DEVICE WAS USED IN CONJUNCTION WITH AN UNKNOWN FLUID MANAGEMENT DEVICE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT IS UNKNOWN WHETHER ANY MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION RESULTED FROM THIS EVENT. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Burn(s)

  MAUDE report 23039551 ↗
• MalfunctionSep 9, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE VAPR PREMIERE 90 ELECTRODE DEVICE DID NOT ABSORB WATER. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY, SO THE ASPIRATOR WAS NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004763 ↗
• MalfunctionJun 24, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING THE VAPR PREMIERE 90 ELECTRODE -EA DEVICE, THE SUCTION HAD NOT FUNCTIONED SINCE THE BEGINNING OF THE CASE. THERE WERE NO REPORTS OF DELAYS 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 22322304 ↗
• MalfunctionJun 12, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE VAPR PREMIERE 90 ELECTRODE DEVICE SUCTION FUNCTION DID NOT WORK PROPERLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192906 ↗
• MalfunctionMar 21, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE, THE VAPR PREMIERE 90 ELECTRODE -EA DEVICE WAS JAMMED AND DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE SUCTION FAILED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21666370 ↗
• MalfunctionNov 8, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE VAPR PREMIERE 90 ELECTRODE DEVICE WAS BEING USED WHEN, (APPROXIMATELY 30 MINUTES AFTER THE START OF SURGERY), THE TRANSPIRATION SUDDENLY STOPPED FUNCTIONING, ALTHOUGH BUBBLES WERE PRODUCED. A NEW PRODUCT WAS OPENED AND USED. THERE WAS 30 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20643898 ↗
• MalfunctionSep 6, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT A METAL PIECE OF THE VAPR PREMIERE 90 ELECTRODE -EA DEVICE FELL OFF. IT WAS REPORTED THAT THE FALLEN METAL PIECE WAS REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162602 ↗