VAPR 227302Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705009688), received between Feb 3, 2020 and Mar 31, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT ELECTRODE DEVICE SHORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11596844 ↗
• MalfunctionFeb 3, 2020Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE AFFILIATE BY CUSTOMER'S MAIL THAT DURING AN UNKNOWN PROCEDURE THE VAPR GENERATOR WAS TURNED ON AND STARTED APPROPRIATELY BUT WHEN THE VAPR3.5MMSDEEFFECT21DEG1-PC ELECTRODE-EA WAS PLUGGED IN IT WAS NOT RECOGNIZE BY THE VAPR GENERATOR. THE PROCEDURE WAS COMPLETED USING ANOTHER ELECTRODE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9661144 ↗

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