VAPRRecalls & reported problems across all models
Depuy Mitek, LLC · 30 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,986
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls
- 0
We found 30 models of VAPR by Depuy Mitek, LLC in the FDA's device registry (GUDID). Together they are named in 1,986 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2017 and Sep 30, 2026 — classified as 44 injuries, 1,942 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (363 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported VAPR problems
Device problems
- Infusion or Flow Problem363
- Electrical /Electronic Property Problem353
- Device Remains Activated161
- Suction Failure145
- Output Problem134
- Break131
- Loss of or Failure to Bond130
- Use of Device Problem96
Patient problems
- No Clinical Signs, Symptoms or Conditions1,217
- No Consequences Or Impact To Patient630
- Not Applicable96
- Burn(s)23
- Foreign Body In Patient21
- No Known Impact Or Consequence To Patient11
- Unspecified Tissue Injury8
- No Patient Involvement6
VAPR models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VAPR 225028ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES895 reports
- VAPR 225370ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES427 reports
- VAPR 227204ARTHROSCOPE164 reports
- VAPR 225021ARTHROSCOPE157 reports
- VAPR 228370ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES58 reports
- VAPR 227504ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES54 reports
- VAPR 228504ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES50 reports
- VAPR 225301ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES31 reports
- VAPR 227305ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES27 reports
- VAPR 225361ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES19 reports
- VAPR 225302ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES16 reports
- VAPR 227355ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES12 reports
- VAPR 227312ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES10 reports
- VAPR 227301ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES9 reports
- VAPR 227203ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES7 reports
- VAPR 228305ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES7 reports
- VAPR 225304ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- VAPR 227211ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- VAPR 225312ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- VAPR 225305ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- VAPR 227213ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- VAPR 228203ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- VAPR 225303ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- VAPR 227252ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- VAPR 225360ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- VAPR 227302ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- VAPR 225202ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- VAPR 225203ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- VAPR 227202ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- VAPR 228300ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent VAPR adverse event reports
The 15 most recent reports across all models, 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 24, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891863 ↗MalfunctionSep 22, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858626 ↗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, 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 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 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 16, 2026Overheating of Device
It was reported that during an unspecified surgery, it was noted that the top of the VAPR device 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 50785720 ↗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 15, 2026Electrical /Electronic Property Problem; Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778416 ↗MalfunctionSep 15, 2026Electrical /Electronic Property Problem; Melted
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777581 ↗
Other Depuy Mitek, LLC products
- HEALIX ADVANCE6 models · 873 reports · 2 recalls
- VAPR COOLPULSE2 models · 779 reports
- FMS9 models · 434 reports
- BIOKNOTLESS PANACRYL ETHIBOND3 models · 35 reports · 2 recalls
- LUPINE ORTHOCORD4 models · 112 reports
- QUICKANCHOR ETHIBOND TAPERCUT2 models · 104 reports
- INTRAFIX14 models · 91 reports
- MILAGRO10 models · 88 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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