VAPR 225301Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886705009251), received between Oct 1, 2018 and Dec 19, 2025 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (9 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Melted; Unintended Movement; Melted; Unintended Movement

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, THE VAPR 3.5MM SIDE STR DEVICE WAS USED, SOMETHING LIKE SOFT TISSUE GOT STUCK IN THE COIL PART OF THE DEVICE TIP. THE SURGEON TRIED TO REMOVE IT, BUT THE COIL WAS LOOSENED AND STARTED TO MELT. THE SURGEON STOPPED USING THE DEVICE AND USED SUBSTITUTION. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851868 ↗
• MalfunctionDec 18, 2025Electrical /Electronic Property Problem; Output Problem; Electrical /Electronic Property Problem; Output Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BANKART REPAIR ON THE SHOULDER JOINT FOR A RECURRENT SHOULDER DISLOCATION PROCEDURE, IT WAS OBSERVED THAT THE VAPR 3.5MM SIDE STR -EA DEVICE SUDDENLY STOPPED WORKING. THE ERROR CODE WAS UNKNOWN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840313 ↗
• MalfunctionJan 29, 2025Use of Device Problem; Contamination /Decontamination Problem; Use of Device Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE VAPR 3.5MM SIDE STR - DEVICE DID NOT FUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING. 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 21267279 ↗
• MalfunctionDec 31, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT AT FIRST, THE SURGEON USED THE VAPR 3.5MM SIDE STR-EA DEVICE WITHOUT ANY PROBLEM, BUT THERE WERE TIMES WHEN IT STOPPED ENERGIZING IN THE MIDDLE OF USE. 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 21047584 ↗
• MalfunctionOct 16, 2024Use of Device Problem; Blocked Connection; Use of Device Problem; Blocked Connection

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) ON SHOULDER JOINT FOR ROTATOR CUFF TEAR SURGICAL PROCEDURE ON AN UNKNOWN DATE THE 4580 FMS DUO+ PUMP/SHAVER DEVICE CONNECTED TO THE HANDPIECE, BUT IT DID NOT RESPOND, SO IT WAS REATTACHED TWICE BUT THERE WAS NO CHANGE. THE SURGEON REATTACHED THE CORD, BUT THERE WAS NO RESPONSE AS WELL. WHEN A SPARE DEVICE WAS USED, IT RESPONDED, SO THE PRODUCT IN QUESTION WAS DEFECTIVE. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A SPARE DEVICE. 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 20462822 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED BY AN AFFILIATE IN JAPAN AFTER UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE VAPR 3.5MM SIDE STR -EA DEVICE A FOREIGN OBJECT IN THE PATIENT¿S BODY WAS CONFIRMED USING X-RAYS. AS A RESULT OF AN IN-HOSPITAL INVESTIGATION, IT WAS DISCOVERED THAT THE COIL AT THE TIP OF THE VAPR PROBE WAS MISSING, AND THERE WAS A HIGH POSSIBILITY THAT THE FOREIGN OBJECT WAS THE BROKEN VAPR PROBE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18074897 ↗
• MalfunctionSep 29, 2023Device Contaminated During Manufacture or Shipping; Material Deformation; Device Contaminated During Manufacture or Shipping; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN TAIWAN THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TIP ON THE SIDE EFFECT ELECTRODE DEVICE WAS SOFT AND DEFORMED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS IN USED CONDITION WITH TISSUE DEBRIS AROUND THE ACTIVE TIP. 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 17844106 ↗
• MalfunctionJun 29, 2023Electrical /Electronic Property Problem; Output Problem; Electrical /Electronic Property Problem; Output Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2023, A SIDE EFFECT ELECTRODE DEVICE WAS USED. ACCORDING TO THE REPORT, THE SURGEON COULD NOT BURN WITH THE DEVICE. IT WAS REPORTED THAT AFTER A FEW ACTIVATIONS OF THE DEVICE, IT STOPPED WORKING. IT WAS FURTHER REPORTED THAT AN ERROR MESSAGE APPEARED, AND THE SURGEON PRESSED THE RESET BUTTON BUT IT DID NOT WORK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231220 ↗
• MalfunctionJun 2, 2023Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPOR SIDE EFFECT ELECTRODE 3.5 MM X 160 MM DEVICE WAS NOT ENERGIZED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE DID NOT ACTIVATE DURING FUNCTIONAL TESTING. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17056238 ↗
• MalfunctionApr 4, 2023Break; Output Problem; Power Problem; Break; Output Problem; Power Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SIDE EFFECT ELECTRODE DEVICE WAS NOT ENERGIZED AND COULD NOT BE USED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE CONTINUITY TESTING FOUND A BREAK IN THE ACTIVE CIRCUIT, WHICH PREVENTED THE DEVICE FROM ACTIVATING. IT WAS FURTHER DETERMINED THAT THE BREAK WAS LOCATED TO THE SIDE OF THE ACTIVE SOLDER JOINT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674118 ↗
• MalfunctionSep 9, 2022Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SIDE EFFECT ELECTRODE DEVICE WAS NOT RECOGNIZED BY THE GENERATOR DEVICE. ACCORDING TO THE REPORT, WHEN THE GENERATOR DEVICE WAS TURNED ON, IT DISPLAYED ¿INVALID INSTRUMENT.¿ IT WAS FURTHER REPORTED THAT ATTACHING A HANDPIECE DID NOT CORRECT THE ISSUE, AND THE GENERATOR DEVICE KEPT SHOWING ¿INVALID INSTRUMENT.¿ THE GENERATOR WAS REPLACED WHICH FINALLY CORRECTED THE ISSUE. 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 15393601 ↗
• MalfunctionAug 17, 2022Output Problem; Physical Resistance/Sticking; Output Problem; Physical Resistance/Sticking

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2022, IT WAS OBSERVED THAT THE SIDE EFFECT ELECTRODE DEVICE WOULD INDICATE FREQUENTLY ¿PRESS MODE TO USE¿ IMMEDIATELY AFTER THE START OF USE. ACCORDING TO THE REPORT, THERE SEEMED TO BE A POOR CONNECTION THAT WHEN THE SURGEON PRESSED THE ARROW IN THE MIDDLE, THE ELECTRODE COULD BE USED FOR A WHILE. BUT IT IMMEDIATELY HAD A POOR CONNECTION THAT IT COULD NOT BE USED. IT WAS FURTHER REPORTED THAT ¿CUT/COAG STUCK¿ WAS DISPLAYED SOME TIMES AND COULD NOT BE USED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHIN 30 MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241131 ↗
• MalfunctionAug 4, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE SALES REP IN TAIWAN THAT THE PLASTIC CASING OF THE SIDE EFFECT ELECTRODE DEVICE WAS CURLED AND DEFORMED AFTER IT WAS UNPACKED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163963 ↗
• MalfunctionJun 29, 2022Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available; Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT THE SIDE EFFECT ELECTRODE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ADHESIVE WAS VISIBLE BETWEEN THE SPRING COILS ON THE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853195 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE BLACK COATED AREA (CLOSE TO THE INSULATOR) ON THE SIDE EFFECT ELECTRODE DEVICE PEELED OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14696775 ↗
• MalfunctionMar 10, 2022Blocked Connection; Output Problem; Blocked Connection; Output Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE VAPR 3.5MM SIDE STR ELECTRODE DEVICE DID NOT START AT ALL WHEN CONNECTED TO A HANDPIECE. 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 13723802 ↗
• MalfunctionDec 9, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT BOTH VAPORIZATION AND COAGULATION FEATURES ON THE VAPR 3.5MM SIDE STR DEVICE WERE OUT OF ORDER FROM THE BEGINNING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12969730 ↗
• MalfunctionSep 27, 2021Power Problem; Power Problem

  IT WAS REPORTED BY THE AFFILIATE IN THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DEVICE WAS. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THERE WAS A RESIDUE AROUND THE ACTIVE TIP AND CERAMIC ON THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532602 ↗
• MalfunctionJun 28, 2021Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR 3.5MM SIDE STR ELECTRODE DEVICE WAS NOT RECOGNIZED BY THE HANDPIECE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12078828 ↗
• MalfunctionMay 27, 2021Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR 3.5MM SIDE STR ELECTRODE DEVICE WAS NOT RECOGNIZED BY THE MAIN UNIT WHEN IT WAS ATTACHED TO IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICES WERE BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896039 ↗
• MalfunctionMay 27, 2021Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR 3.5MM SIDE STR ELECTRODE DEVICE WAS NOT RECOGNIZED BY THE MAIN UNIT WHEN IT WAS ATTACHED TO IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICES WERE BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895982 ↗
• MalfunctionApr 7, 2021Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE CONNECTIVITY OF THE ELECTRODE DEVICE WAS NOT CONFIRMED BY THE MAIN UNIT. THE ELECTRODE WAS UNPLUGGED AND PLUGGED SEVERAL TIMES BUT DID NOT CORRECT THE ISSUE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11629402 ↗
• MalfunctionSep 18, 2020Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT THIS WAS AN ARCR (ARTHROSCOPIC ROTATOR CUFF REPAIR) PERFORMED ON (B)(6) 2020. PREOPERATIVELY THE HANDPIECE WAS CONNECTED TO THE MAIN UNIT, BUT THE UNIT DID NOT RECOGNIZE THE HANDPIECE. ON THE OTHER HAND, A REPLACING HANDPIECE WAS CONNECTED WITHOUT AN ISSUE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10557522 ↗
• MalfunctionFeb 4, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED BY THE AFFILIATE THAT DURING AN ARTHROSCOPIC MENISCAL ABLATION PROCEDURE TREATING MENISCAL AFTER THE PROCEDURE WAS COMPLETED WITH THE VAPR 3.5MM SIDE STR -EA AND THE VAPR HANDPIECE *EA WITH NO ISSUES. POST-OPERATIVELY IT WAS FOUND THAT THE SEGMENT THAT WAS CONNECTING THOSE DEVICES BURNED WHEN THEY WERE DISCONNECTED. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664665 ↗
• MalfunctionJan 29, 2020Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE AFFILIATE THAT DURING AN UNKNOWN PROCEDURE TREATING THE FOOT JOINT, WHEN THE VAPR 3.5 MM SIDE STR EA WAS CONNECTED TO THE GENERATOR IT WAS NOT RECOGNIZED. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641485 ↗

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