VAPR 227504Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10886705009923), received between Sep 18, 2018 and Sep 30, 2026 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (17 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 54 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 50950033 ↗
• MalfunctionSep 30, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950032 ↗
• MalfunctionSep 21, 2026Electrical /Electronic Property Problem; Melted; Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846828 ↗
• MalfunctionSep 21, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846281 ↗
• MalfunctionSep 18, 2026Electrical /Electronic Property Problem; Melted; Infusion or Flow Problem

  It was reported that during service and evaluation, it was determined that the VAPR device has suction failure and a melted manifold. It was noted in the service order that during meniscus repair surgery, the VAPR device would not 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 50817053 ↗
• MalfunctionSep 15, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776423 ↗
• MalfunctionAug 18, 2026Electrical /Electronic Property Problem; Melted; Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50307330 ↗
• MalfunctionJun 11, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE VAPR PREMIERE50 ELECTRODE DEVICE NOTED SPARKS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477994 ↗
• MalfunctionJun 2, 2026Electrical /Electronic Property Problem; Output Problem

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE VAPR DEVICE DID NOT CUT AFTER ABOUT 5 MINUTES OF USE. CHANGED TO ANOTHER VAPR DEVICE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359101 ↗
• MalfunctionJun 2, 2026Electrical /Electronic Property Problem; Output Problem

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE VAPR DEVICE DID NOT CUT AFTER ABOUT 5 MINUTES OF USE. CHANGED TO ANOTHER VAPR DEVICE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359092 ↗
• MalfunctionApr 6, 2026Output Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LIGAMENT RECONSTRUCTION SURGERY, IT WAS NOTED THAT A VAPR ELECTRODE SUDDENLY STOPPED WORKING. A SECOND VAPR ELECTRODE WAS USED TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788414 ↗
• MalfunctionApr 6, 2026Output Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LIGAMENT RECONSTRUCTION SURGERY, IT WAS NOTED THAT A VAPR ELECTRODE SUDDENLY STOPPED WORKING. A SECOND VAPR ELECTRODE WAS USED TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788408 ↗
• MalfunctionMar 5, 2026Electrical /Electronic Property Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE VAPR PREMIERE50 ELECTRODE DEVICE HAD VISUAL: FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. IT WAS NOTED IN THE SERVICE ORDER THAT DURING HIP ARTHROSCOPY SURGERY, THE DEVICE WOULD NOT CUT. 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 24524498 ↗
• MalfunctionJan 29, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VAPR PREMIERE50 ELECTRODE -EA DEVICE COULD NOT COAGULATE, THE COAGULATION OF BLADE DID NOT WORK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 24215123 ↗
• MalfunctionJul 15, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE VAPR PREMIERE50 ELECTRODE DEVICE WAS UNABLE TO COAGULATE OR FUNCTION. 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 22511605 ↗
• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE GASKET AT THE TIP OF THE BLADE OF THE VAPR PREMIERE50 ELECTRODE DEVICE HAD COME OFF. IT WAS REPORTED THAT ANOTHER VAPR PREMIERE50 ELECTRODE DEVICE WAS USED, AND THE SAME PROBLEM OCCURRED. 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308874 ↗
• MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE GASKET AT THE TIP OF THE BLADE OF THE VAPR PREMIERE50 ELECTRODE DEVICE HAD COME OFF. IT WAS REPORTED THAT ANOTHER VAPR PREMIERE50 ELECTRODE DEVICE WAS USED, AND THE SAME PROBLEM OCCURRED. 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293601 ↗
• MalfunctionJan 7, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VAPR PREMIERE50 ELECTRODE -EA DEVICE THAT ONE OF THE TWO DEVICES THAT WERE SENT HAD THE WRONG LOT NUMBER, IT HAD BEEN MISPACKED. THERE WAS A SURGICAL DELAY TO THE WRONG ITEM. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091428 ↗
• MalfunctionJan 3, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE POWER OF THE VAPR PREMIERE50 ELECTRODE DEVICE COULD NOT BE ADJUSTED, AND THE DEVICE GENERATED SPARKS AND COULD NOT COAGULATE. IT WAS REPORTED THAT THE DEVICE COULD NOT EFFECTIVELY STOP BLEEDING, RESULTING IN A BLURRED SURGICAL FIELD. THERE WAS PROLONGED OF THE OPERATION TIME AND INCREASED BLOOD LOSS. SUBSEQUENTLY, THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 21071868 ↗
• MalfunctionJun 12, 2024Blocked Connection; Output Problem; Blocked Connection; Output Problem

  REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE PERFORMED ON (B)(6) 2024, IT WAS OBSERVED THAT WHEN CONNECTING THE VAPR PREMIERE50 ELECTRODE-EA DEVICE AND VAPR VUE WIRELESS FOOTSWITCH DEVICE TO THE VAPR VUE GENERATOR DEVICE AFTER STEP THE FOOTSWITCH, IT WAS FOUND SOMETIMES THE DEVICE HAD NO FEEDBACK, AND SOMETIMES IT WORKED INTERMITTENTLY. ANOTHER LIKE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19517480 ↗
• MalfunctionMay 8, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED FROM CHINA THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VAPR PREMIERE50 ELECTRODE -EA DEVICE WOULD NOT COAGULATE. ANOTHER LIKE DEVICE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274117 ↗
• MalfunctionSep 11, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING THE OPERATION, THE DEVICE HAD THE IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE PREMIERE50 ELECTRODE DEVICE HAD AN OUTPUT SHORT ISSUE. 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 17720579 ↗
• MalfunctionJun 15, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A UNILATERAL BIPORTAL ENDOSCOPIC SPINE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE PREMIERE50 ELECTRODE DEVICE COULD NOT CUT AND COULD NOT COAGULATE. 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 17135627 ↗
• MalfunctionApr 27, 2022Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE IN THAT DURING A KNEE ARTHROSCOPY SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE VAPR PREMIERE50 ELECTRODE DEVICE DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE DID NOT COAGULATE NOR ABLATE. 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 14223581 ↗
• MalfunctionJul 6, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING RADIOFREQUENCY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR PREMIERE50 ELECTRODE DEVICE DID NOT PERFORM ABLATION NOR COAGULATION. 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 12122995 ↗