Coblation ASHA4250-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 219 adverse event reports that list this exact device (DI 00817470000016), received between Oct 24, 2017 and Mar 6, 2026 — classified as 42 injuries, 177 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (49 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 219 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Self-Activation or Keying; Moisture or Humidity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS NOTICED THAT THE AMBIENT SUPER TURBOVAC WAND ABLATE FUNCTION WAS ACTIVATED ALTHOUGH A FOOT SWITCH WAS NOT PRESSED. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532084 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE ARTHROSCOPY, THE PATIENT HAD SKIN DAMAGE THAT APPEARED TO BE BURNED TISSUE. THE JOINT USED IN COMBINATION WITH THE AMBIENT SUPER TURBOVAC 90 WAS LEAKING WATER, AND IT SEEMS THE WATER TEMPERATURE WAS HIGHER THAN WHAT WAS INDICATED BY THE TEMPERATURE SENSOR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23700299 ↗
• MalfunctionNov 12, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, TWO (2) AMBIENT SUPER TURBOVAC 90 ¨WERE NOT BURNING¨ AND WERE PRODUCING A RED LIGHT WITH AN ERROR MESSAGE. THE PROCEDURE WAS CANCELLED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539179 ↗
• MalfunctionOct 1, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC SURGERY, IT WAS NOTICED THAT AMBIENT SUPER TURBOVAC 90 IFS KEPT ACTIVATING ON ITS OWN WITHOUT THE BUTTONS OR THE FOOT PEDAL BEING PRESSED. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23191664 ↗
• MalfunctionSep 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A MENISCUS INJURY PROCEDURE, THE SMALL METAL POINT OF THE AMBIENT SUPER TURBOVAC 90 IFS FELL INTO THE JOINT CAVITY AND WAS LATER REMOVED WITH FORCEPS. SURGERY WAS COMPLETED WITH A S+N BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059921 ↗
• MalfunctionAug 19, 2025Failure to Conduct; Failure to Conduct

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE AMBIENT SUPER TURBOVAC 90 WAS PRODUCING AN ERROR 7 ON THE SCREEN. 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 22843256 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A PIECE OF THE AMBIENT SUPER TURBOVAC WAND CAME LOOSE. THE BROKEN PIECE WAS ASPIRATED FROM THE PATIENT. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710721 ↗
• MalfunctionJul 20, 2025Self-Activation or Keying; Physical Resistance/Sticking; Self-Activation or Keying; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CONTROL BUTTON OF THE AMBIENT WAND WAS STUCK, CAUSING COAGULATION CONSTANTLY BEING ACTIVATED WITHOUT CONTROL. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22551684 ↗
• MalfunctionJul 10, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT THE DURING AN ARTHROSCOPY, THE AMBIENT SUPER TURBOVAC ABLATE FUNCTION WAS ACTIVATED EVEN THOUGH NO FOOT PEDAL OR HAND SWITCH WAS PRESSED. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468335 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE AMBIENT TURBOVAC'S METAL PART OF THE ELECTRODE WAS NOTICED TO BE MISSING. THE METAL PART WAS RECOVERED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391738 ↗
• MalfunctionJun 12, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE AMBIENT SUPERTUBOVAC ACTIVATED EVEN THOUGH A FOOT CONTROL WAS NOT BEING PRESSED. THE PROCEDURE WAS COMPLETED WITH A 3 MINUTE SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195582 ↗
• MalfunctionApr 1, 2025Device Alarm System; Self-Activation or Keying; Key or Button Unresponsive/not Working; Device Alarm System; Self-Activation or Keying; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT 4 HOURS AFTER THE START OF ARTHROSCOPY, NEAR THE END OF THE SURGERY, WHEN THE AMBIENT SUPER TURBOVAC 90 WAND WAS LEFT OUTSIDE A PATIENT FOR A PERIOD WITHOUT BEING USED, AN ALARM SOUNDED AND THE TEMPERATURE DISPLAY ON THE MONITOR WAS AT 60 DEGREES CELSIUS. AN ABLATE FUNCTION ALSO ACTIVATED EVEN THOUGH A FOOT CONTROL AND HAND SWITCH WERE NOT BEING PRESSED. THE SURGEON UNPLUGGED AND RE-PLUGGED THE FOOTSWITCH SEVERAL TIMES WITH NO IMPROVEMENT, AND WHEN THE WAND WAS RE-PLUGGED, THE ALARM SOUNDED AND OUTPUT CONTINUED IN THE SAME MANNER. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS A DELAY OF 10 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749172 ↗
• MalfunctionDec 19, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER 30 MINUTES THE AMBIENT SUPER WAND STARTED TO GIVE AN ERROR AND STOPPED WORKING WITHOUT PRODUCING COAGULATION. THE PROCEDURE WAS 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 20978221 ↗
• MalfunctionNov 28, 2024Insufficient Device Problem Information; Noise, Audible; Unexpected Shutdown; Insufficient Device Problem Information; Noise, Audible; Unexpected Shutdown

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN AMBIENT SUPER TURBOVAC BEGAN TO BEEP AND FAILED TO OPERATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A COMPETITOR BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20806621 ↗
• MalfunctionNov 5, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, WHEN TURNING ON THE WAND, IT GOT HOT AND THE TEMPERATURE COULD NOT BE STABILIZED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615051 ↗
• MalfunctionOct 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, ONE OF THE ELECTRODES CAME OFF FROM THE AMBIENT TURBOVAC WAND AND FELL INTO THE PATIENT. THE ELECTRODE WAS REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522779 ↗
• MalfunctionSep 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE TURBOVAC 90 SUCTION CANNULA WAS RELEASED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242012 ↗
• InjurySep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE AMBIENT SUPER TURBOVAC WAND ELECTRODE DETACHED FROM THE TIP AND FELL INSIDE THE PATIENT, LEAVING A FRAGMENT REMAINING IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE, BUT IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20169443 ↗
• MalfunctionAug 23, 2024Failure to Deliver Energy; Self-Activation or Keying; Failure to Deliver Energy; Self-Activation or Keying

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE TURBOVAC WAND'S ABLATE FUNCTION WAS ACTIVATED EVEN THOUGH NO HAND BUTTON OR FOOT PEDAL WAS PRESSED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A 5 MINUTE SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055114 ↗
• MalfunctionAug 5, 2024Circuit Failure; Insufficient Device Problem Information; Circuit Failure; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THREE AMBIENT SUPER TURBOVAC 90 WANDS FAILED. THE FIRST WAND WAS CONNECTED TO THE CONTROLLER AND DID NOT WORK. THE OTHER TWO WERE CONNECTED AND WORKED INITIALLY, BUT QUICKLY STOPPED WORKING. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. 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 19913929 ↗
• MalfunctionJul 8, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ABLATE FUNCTION OF THE SUPER TURBOVAC WAS ACTIVATED EVEN THOUGH NO HAND BUTTON OR FOOT PEDAL WAS PRESSED. NO ERROR ALARMS WERE GENERATED. NO PATIENT INJURY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689490 ↗
• MalfunctionJun 21, 2024Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE TURBOVAC WAND WAS "EXPIRED" ON ITS FIRST USE . SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584549 ↗
• MalfunctionMay 14, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, TWO (2) SUPER TURBOVAC 90 WERE DISPLAYING AN ¨7 ERROR¨ MESSAGE WHEN CONNECTED TO THE TERMINAL. THE PROCEDURE WAS COMPLETED WITH A S+N 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 19312581 ↗
• MalfunctionApr 16, 2024Overheating of Device; Suction Problem; Overheating of Device; Suction Problem

  IT WAS REPORTED THAT DURING SET UP, THE SUCTION OF THE SUPER TURBOVAC WAS DEFECTIVE AND THE ELECTRODE OVERHEATED. THERE WAS NO DAMAGE CAUSE TO THE USER. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117846 ↗
• MalfunctionApr 11, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE BLACK OUTER COATING OF THE AMBIENT SUPERTURBOVAC WAND WAS FLAKING INTO THE JOINT SPACE. THERE WAS A DELAY OF LESS THAN 30 MIN· THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094242 ↗