VAPR 227312Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705009725), received between Feb 8, 2019 and Apr 23, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Blocked Connection

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE VAPR3.5MM FLEX SIDE EFFECT1-PC ELECTRODE DEVICE DID NOT RESPOND. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973840 ↗
• MalfunctionDec 31, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING KNEE SURGERY, THE VAPR3.5MMFLEXSIDEEFFECT1-PCEELECTRODE-EA DEVICE CERAMIC TOP WAS BREAKING. IT WAS REPORTED THAT THE BROKEN PARTS DID NOT FALL INTO THE PATIENT. 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 21047660 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN POLAND THAT THE VAPR FLEXIBLE SIDE EFFECT ELECTRODE W/INTEGRATED HANDPIECE, 3.5MM X 160MM WAS BROKEN IN THE PATIENT'S BODY. ACCORDING TO THE REPORT, THE PATIENT WAS NOW HAVING KNEE PAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED NOR MEDICAL INTERVENTION REQUIRED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 15789619 ↗
• MalfunctionApr 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SPRING AT THE FRONT END OF THE VAPR FLEXIBLE SIDE EFFECT ELECTRODE W/INTEGRATED HANDPIECE, 3.5MM X 160MM DEVICE FELL OFF. ACCORDING TO THE REPORT, THE OPERATION WAS STOPPED IMMEDIATELY. IT WAS REPORTED THAT THE SPRING WAS FOUND UNDER THE SKIN OF THE PATIENT BY RADIOGRAPHY, AND THE SPRING WAS TAKEN OUT IMMEDIATELY TO CHECK WHETHER IT WAS COMPLETE OR MISSING. 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 14105718 ↗
• MalfunctionOct 8, 2021Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR3.5MMFLEXSIDEEFFECT1-PCEELECTRODE-EA DEVICE WAS NOT RECOGNIZED BY THE CONSOLE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. 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 12599174 ↗
• MalfunctionSep 23, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR3.5MMFLEXSIDEEFFECT1-PCEELECTRODE-EA DID NOT FUNCTION AFTER IT WAS CONNECTED TO THE GENERATOR; AND THAT THE SCREEN DID NOT SHOW ANY ALERT CODE AT ALL. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ABLATE AND COAGULATION ACTIVATION COULD NOT BE PERFORMED. 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 12519287 ↗
• MalfunctionJun 22, 2021Use of Device Problem; Improper Flow or Infusion; Use of Device Problem; Improper Flow or Infusion

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR FLEXIBLE SIDE EFFECT ELECTRODE W/INTEGRATED HANDPIECE, 3.5MM X 160MM DEVICE DISPLAYED ERROR MESSAGES: 300 AND 400. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE DID NOT COAGULATE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040073 ↗
• MalfunctionDec 18, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN EXCISION OF BURSA, IT WAS OBSERVED THAT THE VAPR FLEXIBLE SIDE EFFECT ELECTRODE W/INTEGRATED HANDPIECE, 3.5 MM X 160 MM DEVICE, WAS NOT ABLE TO ABLATE NOR COAGULATE. IT WAS REPORTED THAT THERE WAS NO ALERT CODE SHOWED ON THE SCREEN. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT OF THE DEVICE. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9489589 ↗
• MalfunctionNov 21, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  DOES NOT FUNCTION. IT WAS REPORTED THAT DURING THE MENISCUS PLASTY SURGERY, CONNECT WITH GENERATOR, DID NOT WORK (COULD NOT CUT AND COULD NOT COAGULATE), NO ALERT CODE SHOWED IN THE SCREEN. 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 Consequences Or Impact To Patient

  MAUDE report 9356334 ↗
• InjuryFeb 8, 2019Excessive Heating; Suction Failure; Excessive Heating; Suction Failure

  IT WAS REPORTED BY THE AFFILIATE VIA E-MAIL THAT THE VAPR 3.5 FLEXIBLE PRODUCT WORKS IRREGULARLY DURING SURGERY. IT WAS NECESSARY TO DISCONNECT AND RECONNECT IT. IT DID NOT PERFORM COAGULATION OR ABLATION AND STOPPED WORKING. IT WAS REPORTED BY THE SURGEON THAT THE PRODUCT STEM INCREASES TEMPERATURE. LATER THE PATIENT HAD COMPLAINED OF HAVING BEEN BURNT WITH AN INJURY COMPATIBLE WITH THE INCREASE OF TEMPERATURE OF THE STEM OF THE FLEXIBLE DURING THE SURGERY. THE CENTER HAS DISCARDED THE PRODUCT SO IT WILL NOT BE SENT. THE TYPE OF PROCEDURE WAS NOT INFORMED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON 01/14/2019 STATING THAT THE PATIENT COMPLAINED OF A BURN TO THE DOCTOR. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON 01/24/2019 STATING THAT THERE WAS A 15 MINUTE SURGICAL DELAY DUE TO THIS MALFUNCTION. AN ALTERNATIVE PRODUCT WAS NOT READILY AVAILABLE. THE AFFILIATE ALSO STATED THAT DURING THE PROCEDURE THE FAILURE WAS NOTED BECAUSE THE FLEXIBLE HAD BEEN WORKING IRREGULARLY. THE BURN WAS NOT NOTED OR IDENTIFIED DURING THE SURGERY. THE DOCTOR REPORTS THAT THE PATIENT HAS A MEDIUM BURN, SHE MADE CLEARLY NOTICED HER DISCOMFORT, THE SURGEON INDICATED THAT IT WAS A LOW DE

  Patient problems: Burn(s); Not Applicable

  MAUDE report 8323796 ↗

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