VAPR 227213Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705009640), received between Dec 6, 2019 and Feb 2, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN AUSTRIA THAT DURING A WRIST PROCEDURE ON (B)(6) 2024, A VAPR2.3MM WEDGESHRT 1-PCE ELECTRODE DEVICE WAS USED. ACCORDING TO THE REPORT, THERE WERE METAL PARTS OBSERVED IN THE WRIST BUT WERE REMOVED SUCCESSFULLY. 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 18631713 ↗
• MalfunctionMar 17, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE VAPR2.3MM WEDGESHRT 1-PCE ELECTRODE -EA DID NOT WORK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844805 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THAT DURING ARTHROSCOPY THE VAPR2.3MM WEDGESHRT 1-PCE ELECTRODE -EA HAS BROKEN. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9814297 ↗
• MalfunctionDec 6, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL, THAT THE VAPR ELECTRODE WOULDN'T FUNCTION DURING AN UNKNOWN PROCEDURE. THE AFFILIATE REPORTED THE CASE WAS SUCCESSFULLY COMPLETED WITH A SECOND ELECTRODE AND IT WAS UNKNOWN IF PATIENT OR USER HARM OCCURRED. THE AFFILIATE WAS NOT ABLE TO PROVIDE ADDITIONAL DETAILS. DURING AN IN-HOUSE EVALUATION, IT WAS OBSERVED THAT THE ELECTRODE WOULD NOT OUTPUT. THE DEVICE WAS SENT TO THE SUPPLIER FOR AN IN-DEPTH EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9432950 ↗

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