Coblation ASH4250-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00817470006506), received between Oct 20, 2018 and Mar 2, 2026 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (5 reports).

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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, IT WAS NOTICED THAT THE ELECTRODE HEAD OF THE SUPER TURBOVAC 90 WAND FELL OFF. THE PROCEDURE WAS RESUMED, USING AN S+N EQUIVALENT BACK UP PRODUCT, HOWEVER IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484315 ↗
• MalfunctionFeb 12, 2026Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE SUPER TURBOVAC WAND CONTINUOUSLY COAGULATED ON ITS OWN WITHOUT ANY INTERVENTION. THE PROCEDURE WAS RESUMED USING THE SAME S+N DEVICE. IT WAS CONFIRM THAT A DELAY OCCURRED, BUT THE LENGTH OF THE DELAY REMAINS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324326 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER JOINT SURGERY, THE FRONT END OF A SUPER TURBOVAC WAND CAME OFF. THE PIECE WAS REMOVED FROM THE PATIENT USING SUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704036 ↗
• MalfunctionSep 9, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SUPER TURBOVAC WAS UNABLE TO OPERATE EVEN WHEN SET TO POWER LEVEL OF 9. HOWEVER, THE PLASMA DISPLAY WAS FUNCTIONING NORMALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005200 ↗
• MalfunctionJun 16, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT ONE (1) SUPER TURBOVAC 90 PLASMA HANDLE WAS OVERHEATING. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213070 ↗
• MalfunctionJun 1, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE INTERNAL TO PATIENT, THE SUPER TURBOVAC 90 IFS HAD AN ABNORMAL HEAT AT THE HANDLE AREA EVEN THOUGH THE COAGULATION AND CUTTING FUNCTION OF THE PLASMA SURGERY SYSTEM WAS NORMAL. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE AND IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121095 ↗
• MalfunctionDec 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY ARTHROSCOPY, THE FRONT OF THE SUPER TURBOVAC 90 IFS FELL OFF. THE DETACHED PART FELL INTO THE PATIENT'S BODY AND WAS FLUSHED OUT WITH A SALINE SOLUTION. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20980994 ↗
• MalfunctionJul 10, 2024Self-Activation or Keying; Failure to Shut Off; Self-Activation or Keying; Failure to Shut Off

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE ELECTRODE OF THE SUPER TURBOVAC CONTINUOUSLY OPERATED AFTER APPROXIMATELY 10 MIN OF OPERATING TIME. IT COULD ONLY BE STOPPED BY PULLING THE PLUG ON THE CONSOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 5 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO BURN CAUSED TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714084 ↗
• MalfunctionMay 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUPER TURBOVAC 90 WAND WAS NOT WORKING WHEN CONNECTED TO THE CONSOLE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279916 ↗
• MalfunctionFeb 5, 2024Device Alarm System; Obstruction of Flow; Noise, Audible; Device Alarm System; Obstruction of Flow; Noise, Audible

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUPER TURBOVAC 90 WAND WAS BLOCKED AND THE TEMPERATURE ALARM WENT OFF, PREVENTING ITS USE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639775 ↗
• MalfunctionJan 4, 2024Failure to Conduct; Melted; Protective Measures Problem; No Apparent Adverse Event; Failure to Conduct; Melted; Protective Measures Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION IN AN ARTHROSCOPY, THE SUPER TURBOVAC WAND HAD AN ERROR MESSAGE WHEN PLUGGED IN. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT. AS PER THE RESULTS OF THE INVESTIGATION, THE VISUAL INSPECTION SHOWED THE BLACK SHRINK WRAP HAS BEEN MELTED IN TWO SEPARATE LOCATIONS, ONE CORRESPONDING TO A DAMAGED SHAFT INSULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18448678 ↗
• MalfunctionDec 10, 2023Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A MENISCECTOMY, THE SUPER TURBOVAC TIP WOULD NOT WORK WHEN IT WAS CONNECTED TO THE CONSOLE. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES, AND USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298606 ↗
• MalfunctionJul 13, 2023Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, WHEN THE AMBIENT SUPER TURBOVAC WAND WAS CONNECTED TO THE QUANTUM 2 CONSOLE AN ERROR MESSAGE STATING THE DEVICE WAS OUT OF DATE WAS DISPLAYED, EVEN THOUGH THE DEVICE HAS NOT EXPIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE, A SURGICAL DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319234 ↗
• MalfunctionMar 24, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT, DURING A KNEE PROCEDURE, WHILE THE PATIENT WAS ASLEEP, THE BLUE COAGULATION BUTTON OF THE SUPER TURBOVAC WAND WAS PRESSED BUT DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13874072 ↗
• MalfunctionMar 24, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, WHILE THE PATIENT WAS ASLEEP, THE BLUE COAGULATION BUTTON OF THE SUPER TURBOVAC WAND WAS PRESSED BUT DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13873808 ↗
• MalfunctionMay 31, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE THE SUPER TURBOVAC OVERHEATED, THERE WAS A RISK OF BURNS. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. IN ADDITION, THERE WAS A NON SIGNIFICANT DELAY IN THE INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11910667 ↗
• MalfunctionFeb 9, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY THE WAND WAS CONNECTED FOR THE FIRST TIME AND TESTED IN THE MACHINE AND IT DID NOT WORK, AN ERROR E4 APPEARED. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305324 ↗
• MalfunctionJan 7, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED, THAT DURING A KNEE ARTHROSCOPY, WHILE USING A SUPER TURBOVAC 90 IFS THE CONTROL UNIT DISPLAYED AN F4 HARDWARE FAILURE. NO PATIENT INJURY WAS EXPERIENCED AND A BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY SHORTER THAN 30 MINUTES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11132207 ↗
• MalfunctionJan 7, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED, THAT DURING A KNEE ARTHROSCOPY, WHILE USING A SUPER TURBOVAC 90 IFS THE CONTROL UNIT DISPLAYED AN F4 HARDWARE FAILURE. NO PATIENT INJURY WAS EXPERIENCED AND A BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY SHORTER THAN 30 MINUTES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11132202 ↗
• InjuryOct 21, 2020Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY THE WAND DROPPED A PIN ( PART OF THE DEVICE) INSIDE THE JOINT. NO OTHER COMPLICATIONS OR SIGNIFICANT DELAY WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10712616 ↗
• MalfunctionOct 4, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY AT THE START OF A CASE ONCE PLUGGED IN, IT STARTED TO ALARM. AFTER UNPLUGGING AND RE-PLUGGING IN, THE WAND STILL CONTINUED TO ALARM. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10624638 ↗
• MalfunctionAug 11, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING SETUP WHEN THE NURSE PLUGGED THE PROBE INTO THE GENERATOR, IT WAS NOT FUNCTIONING. ANOTHER PROBE OF THE SAME REFERENCE WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A DELAY, NO PATIENT INJURIES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10393150 ↗
• MalfunctionJul 10, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE WAND DID NOT CONNECT; THE RF UNIT DID NOT RECOGNIZE THE WAND. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER DETAILS WERE PROVIDED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10257330 ↗
• MalfunctionJul 8, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, THE WAND WAS NOT RECOGNIZED BY THE CONTROL UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10244493 ↗
• MalfunctionAug 8, 2019Flaked; Dull, Blunt; Flaked; Dull, Blunt

  IT WAS REPORTED THAT DURING RIGHT KNEE SCOPE AND LYSIS OF ADHESIONS, THE WAND SHAFT WAS PEELING OFF INSIDE THE JOINT. BLACK PIECES OF THE WAND WERE FLOATING IN THE JOINT THEREFORE SURGEON SUCTIONED THIS OUT WITH ARTHROSCOPIC SHAVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8873474 ↗