VAPR 225304Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705009282), received between Apr 3, 2018 and Jun 10, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Output Problem

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, EVEN IF PUSHING THE FOOT SWITCH, THE VAPR SOMETIMES DID NOT OUTPUT. THE SURGERY WAS COMPLETED WITHOUT ANY ISSUES USING A REPLACEMENT PROBE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455389 ↗
• MalfunctionFeb 24, 2025Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BANKART REPAIR (ABR) SHOULDER PROCEDURE, WHEN THE VAPR 3.5MM END 21 DEG ELECTRODE DEVICE WAS CONNECTED TO A VAPR HANDPIECE, THE MAIN UNIT DID NOT ACHIEVE THE CONNECTION COMPLETION STATE. IT WAS DETERMINED THAT THERE WERE NO PROBLEMS WITH THE HANDPIECE DEVICE BECAUSE OTHER PROBES HAD BEEN USED ALREADY WITH THE HANDPIECE. A NEW PRODUCT WAS OPENED AND CONNECTED WITHOUT ANY PROBLEMS. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453193 ↗
• MalfunctionFeb 22, 2023Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE OF THE SHOULDER ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANGLED END EFFECT ELECTRODE, 21º DEVICE BY A HANDPIECE WHEN IT WAS CONNECTED TO THE HANDPIECE. 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 16419063 ↗
• MalfunctionFeb 21, 2023Electrical /Electronic Property Problem; Use of Device Problem; Detachment of Device or Device Component; Electrical /Electronic Property Problem; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANGLED END EFFECT ELECTRODE, 21º DEVICE DID NOT RUN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE RETURN WIRE WAS NO LONGER SOLDERED TO THE RETURN TUBE. ACCORDING TO THE INVESTIGATION, THE WIRE HAD BECOME DETACHED RESULTING IN NO CONTINUITY ON THE RETURN CIRCUIT; AND THEREFORE, NO ACTIVATION DURING THE ABLATE AND COAGULATE MODE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16412285 ↗
• InjurySep 19, 2018Break; Break

  ON (B)(6) 2018, THE REPORTED DEVICE WAS USED FOR THE SYNOVIAL RESECTION DURING SCREW REMOVAL SURGERY AFTER HTO. AFTER THE SURGERY, THE SURGEON RECOGNIZED THAT THE PROBE TIP WAS BROKEN AND REMAINED IN THE PATIENT¿S BODY. THEN, THE BROKEN FRAGMENT WAS REMOVED FROM THE PATIENT¿S BODY WHEN THE SURGEON PERFORMED ADDITIONAL REMOVAL SURGERY LATER. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 7890772 ↗
• MalfunctionApr 3, 2018Break; Torn Material; Break; Torn Material

  IT WAS REPORTED THAT THE REPORTED DEVICE WAS USED DURING THE SURGERY ON (B)(6) 2018. IT WAS NOTICED THAT THE BLACK COATING ON THE ELECTRODE SHAFT CAME OFF DURING THE PROCEDURE. THEREFORE, THE SURGEON STOPPED USING THE REPORTED DEVICE. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO DELAY IN SURGERY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7394036 ↗