VAPR 227203Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705009619), received between Jul 25, 2018 and Apr 8, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING THE (ACL) ANTERIOR CRUCIATE LIGAMENT RE-SURGERY, THE FRONT CERAMIC CONNECTION WAS REPORTED TO HAVE BROKEN. TO ADDRESS THIS ISSUE AND ENSURE THE CONTINUATION OF THE PROCEDURE, ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT RESULTING FROM THE CERAMIC BREAKAGE OR THE SUBSEQUENT USE OF THE ALTERNATIVE DEVICE. NO FURTHER INFORMATION REGARDING THE INCIDENT COULD BE PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820381 ↗
• MalfunctionJan 29, 2026Output Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, NOTED THE VAPR 2.3MM WEDGE 1-PIECE ELECTRODE DEVICE SUDDENLY STOP WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215494 ↗
• MalfunctionMar 6, 2024Break; Display or Visual Feedback Problem; Break; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING ANTERIOR/POSTERIOR REPAIR PROCEDURE ON (B)(6) 2024, WHEN USING THE VAPR 2.3MM WEDGE 1-PIECE ELECTRODE DEVICE MANY BUBBLES WERE OBSERVED AND IT WAS FOUND THAT THE CERAMIC WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO 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 18847604 ↗
• MalfunctionMar 6, 2024Break; Display or Visual Feedback Problem; Break; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024, WHEN USING THE VAPR 2.3MM WEDGE 1-PIECE ELECTRODE DEVICE MANY BUBBLES WERE OBSERVED AND IT WAS FOUND THAT THE CERAMIC WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO 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 18844467 ↗
• MalfunctionNov 13, 2020Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020, IT WAS OBSERVED THAT THE PROBE ON THE ELECTRODE DEVICE SPARKED WHILE IN USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10837622 ↗
• MalfunctionDec 18, 2018Disconnection; Disconnection

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE VAPR 2.3MM WEDGE 1-PIECE ELECTRODE DEVICE WAS NOT WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WOULD NOT COAGULATE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175283 ↗
• MalfunctionJul 25, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT THE ELECTRODE WOULD NOT COAGULATE. THE BLADE WOULD NOT COAGULATE DURING UNKNOWN PROCEDURE. THERE WAS NO ADVERSE EVENT ON PATIENT REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7719611 ↗

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