VAPR 225028Recalls & reported problems

Summary

The FDA's MAUDE database contains 895 adverse event reports that list this exact device (DI 10886705023103), received between Nov 29, 2017 and Sep 18, 2026 — classified as 19 injuries, 876 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (311 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 895 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Device Remains Activated

  It was reported that during an unspecified surgical procedure it was observed that the VAPR TRIPOLAR 90 SUCTION ELECT device did not stop working automatically after activation. It was reported that the surgeon needed to replace the electrode device and use another device on the same patient. It was reported that there was no error message or warning displayed on the device. The only issue is that the electrode device continued to activate and did not stop as expected. It was reported that there was no delay in the procedure due to the event. It was reported that there was no patient or user harm. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819111 ↗
• MalfunctionSep 17, 2026Infusion or Flow Problem

  It was reported that during an unknown surgery, the VAPR device Suction was clogged out of the box. 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 50801610 ↗
• MalfunctionSep 16, 2026Overheating of Device

  It was reported that during an unspecified arthroscopic surgical procedure, while using an unknown three-pole electrode device, the surgeon manually adjusted the power of the equipment to its maximum level, which resulted in water spraying at a very high temperature, directly impacting the patient's operated arm. It was further reported that the hot fluid caused a superficial burn on the first layer of the skin, accompanied by the formation of blisters in the affected area. It was reported that, at the end of the surgery, the injured area would be covered using a special dressing for burns. It was reported that the patient was stable with burns. All available information has been disclosed.

  Patient problems: Blister; Burn(s)

  MAUDE report 50786659 ↗
• MalfunctionSep 15, 2026Device Remains Activated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779737 ↗
• MalfunctionSep 15, 2026Device Remains Activated

  It was reported that during an unspecified surgical procedure, the VAPR device did not stop automatically after activation. No error message or warning was displayed on the device. The Tripolar continued to activate and did not stop as expected. The Tripolar was replaced and another Tripolar was used on the same patient. There was sixty-minute delay to the surgical procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.Report 1 of 2 for (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779734 ↗
• MalfunctionSep 9, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697645 ↗
• MalfunctionAug 31, 2026Device Remains Activated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531319 ↗
• MalfunctionAug 31, 2026Device Remains Activated; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50528671 ↗
• MalfunctionAug 31, 2026Device Remains Activated; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50528309 ↗
• MalfunctionAug 31, 2026Device Remains Activated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50527778 ↗
• MalfunctionAug 31, 2026Device Remains Activated; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50523460 ↗
• MalfunctionAug 31, 2026Device Remains Activated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50523459 ↗
• MalfunctionAug 31, 2026Device Remains Activated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50523457 ↗
• MalfunctionAug 31, 2026Device Remains Activated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50523455 ↗
• InjuryAug 27, 2026Detachment of Device or Device Component

  It was reported that a hip arthroscopy procedure was performed on a patient on (b)(6)2026, using the VAPR device, among other devices. The device was connected to the VAPR system for the purpose of performing ablation and coagulation during the arthroscopy procedure. Approximately two weeks after the surgery, the patient arrived for a follow-up visit and complained of pain in the surgical area. Imaging examination demonstrated that a metal component had remained in the patient¿s hip. Accordingly, the surgeon scheduled an additional procedure to remove the metal component. This procedure was performed approximately two weeks later, and the metal component was removed. According to the report, the metal component had detached from the device in question. At this stage, it is not known whether the component broke or became detached. All available information has been disclosed.

  Patient problems: Pain

  MAUDE report 50482452 ↗
• MalfunctionAug 26, 2026Infusion or Flow Problem

  It was reported that during an Arthroscopic Rotator Cuff Repair surgery, the suction of the VAPR became clogged immediately after the product was put into use. Although measures were taken to clear the blockage, the issue was not resolved. There was a surgical delay of about 30 minutes using a different product. There was no harm to the patient. The device was brand new and the first use when the issue occurred. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50450105 ↗
• MalfunctionAug 25, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438440 ↗
• MalfunctionAug 20, 2026Device Damaged Prior to Receipt by User

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50352364 ↗
• MalfunctionAug 19, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329404 ↗
• MalfunctionAug 19, 2026Device Remains Activated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324957 ↗
• MalfunctionAug 18, 2026Device Remains Activated

  Patient problems: Burn(s)

  MAUDE report 50306074 ↗
• MalfunctionJul 27, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50006541 ↗
• MalfunctionJul 27, 2026Device Remains Activated; Physical Resistance/Sticking

  It was reported that during a Knee Surgery, it was noted the VAPR device start button did not release after being pressed. The device kept working and did not stop, even with the footswitch. There was no fault reported with the footswitch. 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 50005708 ↗
• MalfunctionJun 24, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE VAPR TRIPOLAR 90 SUCTION ELECTRODE DEVICE GENERATED SPARKS. CHANGED ANOTHER TWO 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 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611054 ↗
• MalfunctionJun 24, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE VAPR TRIPOLAR 90 SUCTION ELECTRODE DEVICE GENERATED SPARKS. CHANGED ANOTHER TWO 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 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611050 ↗