Versajet 66800041Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00040565124681), received between Sep 29, 2020 and Jun 18, 2025 — classified as 9 injuries, 69 malfunctions.

The most frequently reported specific device problem is “No Flow” (12 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025No Device Output

  WHILE PREPARING TO START SURGICAL PROCEDURE THE VERSAJET HYDROSURGERY HANDPIECE WAS SET UP FOR USE, YET WHEN THE TEAM WENT TO PRIME THE TUBING FOR SURGEON USE IT DID NOT INITIATE THIS PROCESS. SURGICAL TEAM OBTAINED A NEW HANDPIECE WITH NO ISSUE. HANDPIECE SAVED. REF # 66800041, LOT#(10)51287320, EXP: 2/19/2027, MANUFACTURER :SMITH AND NEPHEW.

  Patient problems: Insufficient Information

  MAUDE report 22282743 ↗
• InjuryNov 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT PROCEDURE, IT WAS NOTICED THAT WHEN ATTEMPTING TO USE A VERSAJET EXACT ASSY, 45 DEGREE X 14MM, ITS IRRIGATION LINE KEPT DETACHING. THE PROCEDURE WAS CANCELLED, AND IT IS UNKNOWN IF SURGERY WILL BE COMPLETED LATER IN TIME OR IF PATIENT WAS INVOLVED AT THE TIME. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18218519 ↗
• MalfunctionAug 16, 2023Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow

  IT WAS REPORTED THAT DURING TREATMENT, THE VERSAJET EXACT ASSY, 45 DEGREE X 14MM WOULDN'T ABSORB WATER BACK INTO IT, WON'T CUT TISSUE AND THE MALFUNCTION LIGHT WAS ON. THERE WAS A SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP, WITH A MODIFIED TECHNIQUE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557326 ↗
• MalfunctionAug 2, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT SURGERY, AFTER USING A VERSAJET EXACT ASSY, 45 DEGREE X 14MM FOR FIVE MINUTES, A LOT OF WATER CAME OUT OF THE HANDPIECE AND THEN IT WAS NOT POSSIBLE TO CONTINUE USING IT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACKUP DEVICE. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446800 ↗
• MalfunctionJul 13, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT, DURING PROCEDURE FOR A BURN DEBRIDEMENT PROCEDURE WITH VERSAJET, THE WATER CAME OUT AT THE BACK OF A VERSAJET II EXACT 45DX14 MM, AND NO WATER WAS COMING OUT FROM ITS END AS INTENDED, SO IT COULD NOT BE USED TO CUT. IT WAS CONFIRM THAT THE DEVICE WAS CORRECTLY INSTALLED. AS NO PROBLEM WAS FOUND, A SECOND VERSAJET II EXACT 45DX14 MM WAS USED, BUT IT HAD THE SAME ISSUE. THE PROCEDURE WAS PERFORMED, AFTER SIGNIFICANT DELAY, WITH A THIRD S+N HANDPIECE. IT WAS CONFORMED THAT PATIENT WAS ALREADY ANESTHETIZED DURING THE +30MIN DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319365 ↗
• MalfunctionJul 5, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT DURING A DEBRIDEMENT, IT WAS FOUND THAT VERSAJET II EXACT 45DX14MM, THERE WAS NO WATER CAME OUT. THE HCP RE-CHECK IF THEY SET UP EVERYTHING CORRECTLY BUT STILL NO WATER CAME OUT. SO THEY CHANGE TO THE SECOND VERSAJET II EXACT 45DX14MM SAME BATCH NUMBER FOUND THAT THE WATER CAME OUT BUT NOT ABLE TO CUT THE DEBRIDE BURN. THE PROCEDURE WAS PERFORMED, AFTER SIGNIFICANT DELAY, WITH A S+N BACK-UP HANDPIECE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Burn(s)

  MAUDE report 17263579 ↗
• MalfunctionJul 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT PROCEDURE, THE WATER CAME OUT OF THE KEY OF THE VERSAJET EXACT ASSY, 45 DEGREE X 14MM ONCE CORRECTLY INSERTED INTO THE CONSOLE. THE SURGERY WAS COMPLETED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254010 ↗
• MalfunctionJun 19, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING SURGERY (RE-DEBRIDEMENT OF FULL THICKNESS BURNS ON THE LEFT LEG), AFTER AN HOUR OF USE, THE VERSAJET EXACT ASSY, 45 DEGREE X 14MM BEGAN TO SPRAY LOTS OF WATER. THE PROCEDURE COULDN´T BE COMPLETED AND THE PATIENT REQUIRED RE-DEBRIDEMENTS MORE THAN ONCE, SO IT DIDN¿T AFFECT THE PATIENT¿S CARE IN THE LONG RUN. IT IS UNKNOWN THE CURRENT STATUS OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17159481 ↗
• MalfunctionApr 26, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT DURING DEBRIDEMENT, TWO (2) VERSAJET EXACT ASSY, 45 DEGREE X 14MM FAILED, IN ONE THE WATER DID NOT COME OUT THIS EVENT HAPPENED DURING INSPECTION THEREFORE THERE WAS NO PATIENT INVOLVED AT THAT MOMENT AND THE OTHER DEVICE DID NOT HAVE PRESSURE BUT THERE WAS WATER COMING OUT WITH THE SECOND DEVICE THERE WAS A DELAY GREATER 30 MINUTES WITH PATIENT UNDER ANESTHESIA. PROCEDURE WAS RESUMED, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820798 ↗
• InjuryAug 1, 2022No Pressure; No Pressure

  IT WAS REPORTED THAT DURING DEBRIDEMENT OF A WOUND THE HANDPIECE OF A VERSAJET EXACT ASSY, 45 DEGREE X 14MM NO LONGER PROVIDED PRESSURE AFTER INTERMITTENT USE OF ONE HOUR AND THIRTY MINUTES. THE PROCEDURE HAD A DELAY OF 20 MINUTES, THERE WAS NO BACKUP AVAILABLE AND WAS CONFIRMED THAT IT WAS NOT COMPLETED. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15142793 ↗
• MalfunctionMay 5, 2022Self-Activation or Keying; Material Separation; Noise, Audible

  VERSAJET DEVICE HAD BEEN USED FOR APPROXIMATELY 30 MINUTES WITHOUT ISSUE; HOWEVER DURING PRIMING, SURGEONS DESCRIBE THE DEVICE "WAS GOING FASTER AND FASTER" WITHOUT CHANGING ANY SETTINGS, AND THE DEVICE MADE A LOUD POP NOISE, AND THE CABLES POPPED OFF AND SEPARATED FROM THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 14287801 ↗
• MalfunctionMar 30, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING SURGERY, A VERSAJET EXACT ASSY, 45 DEGREE X 14MM DID NOT HAVE NORMAL FLOW (DIRECTION) OF WATER BEAM. SURGERY WAS FINISHED, AFTER A DELAY OF 30 MINUTES OR LESS, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13957636 ↗
• MalfunctionMar 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED, DURING DEBRIDEMENT, THAT KEVLAR HOSE OF THE VERSAJET EXACT ASSY BLEW OUT OF ORANGE PUMP INTERFACE. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935104 ↗
• MalfunctionFeb 10, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, UPON SET-UP/INSPECTION OF DEBRIDEMENT SURGERY, WHEN A VERSAJET II HYDROSURGERY SYSTEM HANDSET 45DEG 14MM EXACT WAS OPENED, AN OBJECT THAT SEEMED LIKE HUMAN HAIR WAS OBSERVED ON THE DEVICE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13510547 ↗
• MalfunctionDec 10, 2021Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent

  IT WAS REPORTED THAT A VERSAJET II HYDROSURGERY SYSTEM HANDSET, 45DEG 14MM EXACT WAS NOT PERFORMING CORRECTLY. THE TIP SEEMED TO BE "BENT" AND THE STREAM WAS AFFECTED. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12979016 ↗
• MalfunctionDec 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, A HIGH PRESSURE (KEVLAR) HOSE OF A VERSAJET EXACT ASSY, 45 DEGREE X 14MM RUPTURED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974546 ↗
• MalfunctionSep 28, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING TREATMENT, A VERSAJET II HYDROSURGERY SYSTEM HANDSET, 45DEG 14MM EXACT WAS SPLASHING WATER IN THE WRONG DIRECTION. TREATMENT WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544569 ↗
• MalfunctionAug 6, 2021Failure to Cut; Firing Problem; Failure to Cut; Firing Problem

  IT WAS REPORTED THAT DURING A WOUND TREATMENT, A VERSAJET EXACT ASSY, 45 DEGREE X 14MM FAILED TO PERFORM THE CUTTING FUNCTION BECAUSE THE WATER LINE WAS DIVERTED. NO PATIENT DAMAGE REPORTED. PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACKUP DEVICE, NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285709 ↗
• MalfunctionJul 13, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE TIP OF THE VERSAJET II EXACT DISPOSABLE HANDPIECE 45 DEGREE X 14MM MALFUNCTIONED AND HAS FLUID SPRAYING OUT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159815 ↗
• MalfunctionJun 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT SURGERY, A VERSAJET EXACT ASSY, 45 DEGREE X 14MM HAD PIECE TUBING WAS PULLED OUT OF THE ORANGE KEY. THE HAND PIECE WAS SAVED AND DID NOT TOUCH THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089411 ↗
• InjuryJun 14, 2021Break; Break

  IT WAS REPORTED THAT A VERSAJET EXACT ASSY, 45 DEGREE X 14MM WAS DEFECTIVE, IT WAS BROKEN WITH WATER GUSHED OUT. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY/TREATMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995562 ↗
• MalfunctionJun 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT, A VERSAJET EXACT ASSY, 45 DEGREE X 14MM WAS SPRAYING SALINE OUTSIDE OF THE 14MM TREATMENT WINDOW AND THEREFORE NOT FOCUSED ENOUGH TO EXCISE TISSUE. 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 11952538 ↗
• MalfunctionJun 4, 2021Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT DURING THE DEBRIDEMENT UTILIZING A VERSAJET II EXACT DISPOSABLE HANDPIECE 45 DEGREE X 14MM, THE HAND-PIECE SALINE LEAKAGE OCCURRED FROM THE ORANGE CARTRIDGE WHEN PRIMING SALINE. IN ADDITION, THE CARTRIDGE HAS COME OFF THE CONSOLE. THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. NO DELAY REPORTED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939153 ↗
• MalfunctionJun 2, 2021No Flow; No Flow

  IT WAS REPORTED THAT, DURING PREPARATION OF DEBRIDEMENT, TWO VERSAJET EXACT ASSY, 45 DEGREE X 14MM, WATER DID NOT FLOW TO THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918465 ↗
• MalfunctionJun 2, 2021No Flow; No Flow

  IT WAS REPORTED THAT, DURING PREPARATION OF DEBRIDEMENT, TWO VERSAJET EXACT ASSY, 45 DEGREE X 14MM, WATER DID NOT FLOW TO THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918464 ↗