VAPR 227211Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705009633), received between Oct 20, 2020 and Apr 1, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K082643); they may or may not involve this specific model.

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.

• MalfunctionApr 1, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT A VAPR2.3MM SIDE SHRT 1-PCE ELECTRODE DEVICE WAS USED IN THE OPERATING ROOM OF THE SAME HOSPITAL WHERE THE EXPIRY DATE ON THE OUTER PACKAGING DID NOT CORRESPOND TO THAT ON THE INNER PACKAGING. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757512 ↗
• MalfunctionMar 19, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO SURGERY, IT WAS OBSERVED THAT THE VAPR2.3MM SIDE SHRT 1-PCE ELECTRODE DEVICE HAD A MISMATCH IN THE EXPIRATION DATES BETWEEN THE INNER PACKAGE AND THE SALES PACKAGE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL DELAY. 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 24639167 ↗
• MalfunctionFeb 26, 2025Electrical /Electronic Property Problem; Output Problem; Power Problem; Electrical /Electronic Property Problem; Output Problem; Power Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING THE VAPR2.3MM SIDE SHRT 1-PCE ELECTRODE -EA DEVICE, DURING THE MIDDLE OF THE SURGERY, EVAPORATION COULD NOT WORK DUE TO A POOR ENERGIZATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. NO PIECES WERE LEFT IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT. 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 21469845 ↗
• MalfunctionSep 5, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A SURGICAL PROCEDURE OF THE ANKLE IT WAS OBSERVED THAT THE VAPR 2.3 SIDE EFFECT ELECTRODE (SHORT) W/INTEGRATED HANDPIECE, 85MM WAS CLOGGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147432 ↗
• MalfunctionMay 22, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TIP ON THE VAPR 2.3 SIDE EFFECT ELECTRODE (SHORT) W/INTEGRATED HANDPIECE, 85MM DEVICE WAS BROKEN OFF UPON OPENING ITS PACKAGE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 16977014 ↗
• MalfunctionOct 20, 2020Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT THIS WAS AN ARTHROSCOPIC SYNOVECTOMY IN THE ELBOW ON (B)(6) 2020. THE VAR VUE MAIN UNIT DID NOT RECOGNIZE THE ELECTRODE. THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES. THERE WAS NO HARM TO THE PATIENT. THE DEVICES WERE BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE DEVICE WILL NOT BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 10708427 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082643. One submission often covers many models, so check the product and lot details in each record.

• Z-0133-2013 · Mar 12, 2012 · Terminated
  DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency Syste
• Z-2301-2010 · Jun 7, 2010 · Terminated
  Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and V