VAPR 228305Recalls & reported problems
Depuy Mitek, LLC · VAPR Hook Electrode with Hand Controls 3.5mm Hook Electrode with Integrated Handpiece · Class 2
All models of VAPR (30)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705020928), received between Aug 21, 2018 and Aug 3, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Electrical /Electronic Property Problem2
- Appropriate Device Problem Term/Code Not Available1
- Blocked Connection1
- Device Damaged Prior to Use1
- Output Problem1
- Physical Resistance/Sticking1
- Suction Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Impaired Healing1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114106 ↗MalfunctionAug 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113922 ↗MalfunctionNov 14, 2025Electrical /Electronic Property Problem; Physical Resistance/Sticking; Electrical /Electronic Property Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE OF THE KNEE, WHILE USING A VAPR HOOK W/ HAND CONTROLS DEVICE, IT WAS OBSERVED THAT THE COAGULATION WAS NOT WORKING WHEN THE BUTTON WAS PRESSED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO SURGICAL DELAYS AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23554765 ↗MalfunctionJun 17, 2025Electrical /Electronic Property Problem; Use of Device Problem; Device Damaged Prior to Use; Electrical /Electronic Property Problem; Use of Device Problem; Device Damaged Prior to Use
IT WAS REPORTED THAT THE VAPR HOOK W/ HAND CONTROLS DEVICE ELECTRODE WAS DEFECTIVE OUT OF THE BOX. COAGULATION AND THE BLADE DID NOT WORK. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236730 ↗MalfunctionAug 28, 2024Blocked Connection; Output Problem; Blocked Connection; Output Problem
IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE CUSTOMER'S VAPR NO LONGER RECOGNIZED THIS ELECTRODE AND SHOWED THE ERROR MESSAGE ¿FAULTY INSTRUMENT¿ ON THE DISPLAY. ACCORDING TO THE REPORTER THE CUSTOMER DISCONNECTED AND RECONNECTED THE ELECTRODE DURING THE OPERATION AND WAS ABLE TO CONTINUE OPERATING UNTIL THE ERROR OCCURRED AGAIN. IT WAS REPORTED THAT THE ELECTRODE HAD TO BE DISCONNECTED AND RECONNECTED SEVERAL TIMES DURING THE OPERATION. THERE WAS NO SIGNIFICANT 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 20083239 ↗InjuryOct 6, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE PATIENT HAD WOUND HEALING DISORDER AFTER USING VAPR HOOK W/ HAND CONTROLS ELECTRODE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Impaired Healing
MAUDE report 12584124 ↗MalfunctionAug 21, 2018Suction Failure; Suction Failure
IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANKLE RECONSTRUCTION THE CUSTOMER'S VAPR HOOK ELECTRODE WITH HAND CONTROLS WOULD NOT COAGULATE. THE SALES REP STATED THAT THE GENERATOR WAS ON THE DEFAULT SETTING AND THE ELECTRODE IS BRAND NEW AND NOT RE-PROCESSED. THE SALES REP STATED THAT THE ABLATION FEATURE WAS WORKING. THE PROCEDURE WAS COMPLETED WITH A LIKE-DEVICE FROM THE SAME LOT NUMBER WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE DEVICE IS BEING RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7801666 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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