Versajet 66800039Recalls & reported problems

Summary

The FDA's MAUDE database contains 160 adverse event reports that list this exact device (DI 00040565124759), received between Sep 25, 2020 and Jul 26, 2024 — classified as 24 injuries, 136 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 160 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2024Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT, DURING DEBRIDEMENT, WHEN TRYING TO PUT THE HANDPIECE IN THE VERSAJET II CONSOLE IT WAS UNABLE TO TURN THE KEY. THE INLET PORT WAS BROKEN, TWISTED INSIDE. THE DEVICE COULD NOT BE USED AT ALL. THE SURGEON DEBRIDED MANUALLY AND COMPLETED THE PROCEDURE, AFTER A SIGNIFICANT DELAY. NO OTHER INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19844871 ↗
• MalfunctionJul 23, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING DEBRIDEMENT SURGERY, ONE (1) VERSAJET II CONSOLE STOPPED SUCTIONING. THERE WERE AIR BUBBLES NO MATTER HOW MUCH THEY CHANGED THE IV BAG AND TRIED TO GET THE AIR OUT, IT DID NOT WORK. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING A S+N BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812133 ↗
• MalfunctionJun 24, 2024Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT, IT WAS NOTICED THAT THE HANDPIECE IS NOT COMING OUT OF A VERSAJET II CONSOLE. TRIED TO SOLVE ACCORDING TO PRODUCT MANUAL, BUT STILL HANDPIECE DID NOT COME OUT. THE PROCEDURE WAS COMPLETED, AFTER A SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594189 ↗
• MalfunctionJun 18, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING DEBRIDEMENT, ONE (1) VERSAJET II CONSOLE DISPLAYED A RED ALARM LIGHT AND STOPPED WORKING; IT SEEMED TO BE BLOCKED. THE PROCEDURE WAS CANCELED, AND IT REMAINS UNKNOWN IF IT WILL BE COMPLETED LATER IN TIME. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558951 ↗
• MalfunctionFeb 2, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT PROCEDURE, WHEN CHANGING THE IV BAG THE VERSAJET II CONSOLE BLOCKED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, BY CHANGING THE SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636450 ↗
• MalfunctionJun 19, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT AFTER INSERT VERSAJET II EXACT TO THE VERSAJET II CONSOLE, IT CANNOT TURN THE PUMP CARTRIDGE CLOCKWISE. THE PROCEDURE WAS PERFORMED, AFTER SIGNIFICANT DELAY, WITH A CHANGE IN THE TREATMENT. THE PATIENT WAS UNDER ANESTHESIA DURING SUCH DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159584 ↗
• MalfunctionJun 19, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT PROCEDURE, WHEN INSERTING THE HANDSET PUMP CARTRIDGE INTO A VERSAJET II CONSOLE IT COULD NOT BE TURNED CLOCKWISE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A VERSAJET II CONSOLE BACK UP. PATIENT WAS NO INJURED AS CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159552 ↗
• InjuryApr 4, 2023Connection Problem; Noise, Audible; Connection Problem; Noise, Audible

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE VERSAJET II CONSOLE DOES NOT DO ITS FUNCTION, AND MAKES A LOT OF NOISE WHEN USED WITH A 8-POSITION CONNECTION, AND ACCORDING TO THE CUSTOMER, IT DOES NOT WORK WITH THE 14-POSITION CONNECTION. THE PROCEDURE WAS CANCELLED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

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

  MAUDE report 16678585 ↗
• InjuryApr 4, 2023Connection Problem; Noise, Audible; Connection Problem; Noise, Audible

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE VERSAJET II CONSOLE DOES NOT DO ITS FUNCTION, AND MAKES A LOT OF NOISE WHEN USED WITH A 8-POSITION CONNECTION, AND ACCORDING TO THE CUSTOMER, IT DOES NOT WORK WITH THE 14-POSITION CONNECTION. THE PROCEDURE WAS CANCELLED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

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

  MAUDE report 16678573 ↗
• MalfunctionDec 29, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT AT THE BEGINNING OF SURGICAL WASHING, THE HANDPIECE COULD NOT BE CONNECTED TO THE VERSAJET II CONSOLE. THE IGNITION RING OF THE CONSOLE WAS STUCK AND DID NOT ALLOW THE ENTRY OF THE HANDPIECES. THE PROCEDURE WAS COMPLETED, AFTER A SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK UP CONSOLE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16066983 ↗
• MalfunctionNov 29, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING DEBRIDEMENT VERSAJET II CONSOLE VIBRATES, MAKES NOISE, AND DOES NOT WORK. TREATMENT WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN THE TECHNIQUE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882845 ↗
• MalfunctionMar 29, 2022Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT THERE IS SMOKE AND SMELL COMING FROM THE VERSAJET II CONSOLE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13945828 ↗
• MalfunctionMar 28, 2022Failure to Disconnect; Failure to Disconnect

  IT WAD REPORTED THAT, DURING SET-UP/INSPECTION OF A DEBRIDEMENT SURGERY CASE, THE HANDPIECE FAILED TO COME OUT FROM THE VERSAJET II CONSOLE. SURGERY COULD NOT BE PERFORMED AND IT WAS CANCELLED INSTEAD. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13926937 ↗
• MalfunctionMar 20, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, A RENASYS GO WAS OVERHEATING NO CASE INVOLVED; THEREFORE, NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13830770 ↗
• InjuryMar 17, 2022Loss of Power; Noise, Audible; Loss of Power; Noise, Audible

  IT WAS REPORTED THAT, DURING DEBRIDEMENT, WHEN THE PEDAL IS PRESSED NO JET COMES OUT OF THE HANDPIECE. THE VERSAJET II CONSOLE MAKES AN ABNORMAL NOISE AND THEN, AS SOON AS THE FOOT IS REMOVED FROM THE PEDAL, A JET OF SALINE IS MADE AND IT TURNS OFF. IT WAS TESTED WITH ANOTHER HANDPIECE AND DID THE SAME. THE PROCEDURE WAS CANCELLED. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13794534 ↗
• InjuryMar 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE WITH VERSAJET II CONSOLE UTILIZING A VERSAJET II HANDPIECE IN A SURGICAL CASE, THE CARBON CONNECTED TO THE HANDPIECE POPPED. THE POP OF CARBON CAUSED THE FIBER TO HIT THE SURGEON. IT IS UNKNOWN HOW THE PROBLEM WAS SOLVED OR IF THERE WAS A DELAY DUE TO THIS EVENT. NO OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664067 ↗
• MalfunctionFeb 16, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE VERSAJET II CONSOLE HAD A BURNING SMELL AFTER GAUZE WENT INSIDE THE DEVICE UNWITTINGLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542357 ↗
• MalfunctionFeb 10, 2022Overheating of Device; Connection Problem; Overheating of Device; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY THE VERSAJET II CONSOLE OPERATES WITH INTERRUPTIONS WHEN PRESSING THE PEDAL THE CONSOLE WOULD NOT WORK AND THEN MADE A DECELERATION NOISE AS THE MOTOR WOULD DEACCELERATE AND NO FLUID CAME OUT THROUGH THE HANDPIECE. THE MACHINE WAS OVERHEATED AT ONE STAGE OF THE SURGERY. KEEPS HALTING, STOPPING INTERMITTENTLY AND THEN STARTS WORKING AGAIN. THE PROCEDURE WAS COMPLETED, WITH A SIGNIFICANT DELAY, USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505666 ↗
• MalfunctionFeb 8, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT, THE VERSAJET II CONSOLE WAS BROKEN, ALSO CONSOLE CANNOT BE TURNED ON DUE TO FUSE IS BLOWN. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13486535 ↗
• MalfunctionFeb 8, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT PROCEDURE, A VERSAJET II CONSOLE IS CAUSING REPEATED BLOWN FUSES IN THE OPERATION ROOM. TREATMENT WAS RESUMED, AFTER A 10-15 MINUTE DELAY, WITH A CURETTE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13485775 ↗
• InjuryFeb 4, 2022Failure to Prime; Adverse Event Without Identified Device or Use Problem; Failure to Prime; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING DEBRIDEMENT SURGERY, WATER FAILED TO REACH THE HANDPIECE OF A VERSAJET II HYDROSURGERY SYSTEM CONSOLE. BY THE TIME THIS HAPPENED, THE PATIENT WAS ALREADY ANAESTHETIZED, AND IT WAS REPORTED THAT A LOT OF TIME WAS LOST IN THE OPERATING ROOM. THE CONSOLE STARTED UP PROPERLY. THE PURGE WAS DONE, BUT THERE WAS NO WATER IN THE HANDPIECE. THE PROCEDURE COULD NOT BE SUCCESSFULLY COMPLETED, FOR WHICH IT WAS CANCELLED AND POSTPONED. NO INJURY CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13457972 ↗
• MalfunctionJan 4, 2022Overheating of Device; Vibration; Overheating of Device; Vibration

  IT WAS REPORTED THAT, DURING DEBRIDEMENT, A VERSAJET II CONSOLE WAS WARM AND VERY SHAKY, AND SURGEON FELT UNCOMFORTABLE USING IT. IT IS UNKNOWN HOW PROCEDURE WAS PERFORMED AND IF THIS CAUSED A DELAY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13159128 ↗
• MalfunctionSep 30, 2021Break; Melted; Overheating of Device; Smoking; Break; Melted; Overheating of Device; Smoking

  IT WAS REPORTED THAT, DURING WOUND DEBRIDEMENT, THE INTERNAL WIRES OF A VERSAJET II CONSOLE BROKE, MELTED AND THE DEVICE SMOKED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558692 ↗
• MalfunctionSep 27, 2021Failure to Prime; Activation, Positioning or Separation Problem; Failure to Prime; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING SET UP/ INSPECTION, BEFORE A PROCEDURE, THE VERSAJET II CONSOLE TURNED ON BUT WHEN THE PEDAL WAS PRESSED IT DID NOT PURGE THE LINE. THIS LED TO A CHANGE IN THE SURGICAL TECHNIQUE AND A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538153 ↗
• MalfunctionAug 25, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION OCCURRED WITH THE VERSAJET II CONSOLE. NO CASE WAS INVOLVED. DURING PRODUCT INVESTIGATION IT WAS FOUND THAT THE VISUAL EVALUATION FOUND THE FOOTSWITCH PORT DAMAGED. THE FUNCTIONAL EVALUATION WAS UNABLE TO TEST FOOTSWITCH DUE TO THE PORT BEEN DAMAGED. 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 12368480 ↗