VAPR 227202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705009602), received between Jul 17, 2019 and Jul 17, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING A HAND ARTHROSCOPY THE VAPR 2.3 MM ELECTRODE WAS USED BY THE DOCTOR. THE DOCTOR WAS SUED BY THE PATIENT BECAUSE OF EXTENSOR TENDON RUPTURE ALLEGEDLY CAUSED BY THE DOCTOR AS STATED BY THE PATIENT. THE CASE IS YEARS AGO AS STATED BY THE DOCTOR. IT IS UNKNOWN IF THE COMPLAINT IS REALLY PRODUCT RELATED. WHAT IS STATED IS WHAT WAS CONVEYED BY THE DOCTOR. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE DOCTOR COULD NOT PROVIDE ADDITIONAL INFORMATION REGARDING THE EVENT OR THE PRODUCT. THE AFFILIATE ALSO REPORTED THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNING FOR INVESTIGATION.

  Patient problems: Rupture

  MAUDE report 8799641 ↗

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