Versajet 66800042Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00040565124698), received between Apr 30, 2020 and Jun 2, 2025 — classified as 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Failure to Prime” (9 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Activation, Positioning or Separation Problem; Material Integrity Problem

  SURGICAL SUPPLY INOPERABLE. REPLACED WITH AVAILABLE ALTERNATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122404 ↗
• InjuryJul 24, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING DEBRIDEMENT, IT WAS NOTICED THAT A VERSAJET EXACT ASSY, 45 DEGREE X 8MM AND A VERSAJET EXACT ASSY, 45 DEGREE X 14MM WOULD NOT TURN THE KEY, RESULTING IN HAVING TO DEBRIDE MANUALLY. THERE WAS A NON SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISH BY CHANGING THE SURGICAL TECHNIQUE. VIABLE TISSUE WAS ALSO REMOVED. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED ISSUE.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817775 ↗
• MalfunctionDec 5, 2023Material Rupture; Sparking; Material Rupture; Sparking

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT PROCEDURE, THE CABLE OF A VERSAJET EXACT ASSY, 45 DEGREE X 8MM EXPLODED AND SMOKE AND SPARKS WERE SEEN ON THE SEVERED CABLE/WIRE. THE PODIATRIST IMMEDIATELY STOPPED USING IT. THERE WAS NO NOTABLE PATIENT OR USER HARM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, BY CHANGING THE SURGICAL TECHNIQUE TO SHARP SURGICAL DISSECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267499 ↗
• InjurySep 27, 2022Connection Problem; Premature Separation; Connection Problem; Premature Separation

  IT WAS REPORTED THAT, DURING A DEBRIDEMENT PROCEDURE, A VERSAJET II EXACT 45 DEGREE 8MM HANDPIECE FELL OUT. IN ADDITION, THE METAL PLUG FAILED TO CONNECT TO THE CONSOLE. SURGERY WAS COMPLETED, AFTER A 15 MIN DELAY, WITH A BACK-UP HANDPIECE. DURING THIS DELAY, THE PATIENT RECEIVED ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492334 ↗
• MalfunctionMay 5, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING DEBRIDEMENT, BOTH VERSAJET EXACT ASSY, 45 DEGREE X 8MM AND VERSAJET PLUS ASSY, 45 DEGREE X 14MM WERE NOT DRAINING AT ALL AND INSTEAD SPRAYING BACK ALL OVER THE DEBRIDED WOUND BED. PROCEDURE WAS RESUMED, WITH A GREATER THAN 30 MINUTES DELAY, WITH A CHANGED IN SURGICAL TECHNIQUE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN AT THE PRESENT, HOWEVER, WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14290879 ↗
• MalfunctionApr 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING DEBRIDEMENT, TWO (2) VERSAJET EXACT ASSY, 45 DEGREE X 8MM HAVE LEAKED WATER. WATER LINE WAS SPLASHING ALL AROUND INSTEAD OF DIRECT LINE. DEBRIDEMENT WAS PERFORMED, 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 14135325 ↗
• MalfunctionDec 27, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT, DURING WOUND DEBRIDEMENT, THE SALINE FAILED TO GO THROUGH A VERSAJET II HYDROSURGERY SYSTEM HANDPIECE. EVEN TOUGH EVERY CONNECTION WAS CHECKED TO BE CORRECTLY PLACED, THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS RESUMED WITH A BACK-UP HANDPIECE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087624 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING SURGICAL DEBRIDEMENT, THE VERSAJET EXACT ASSY, 45 DEGREE X 8MM MADE LITTLE BLISTERS ON THE SKIN. PATIENT IS (B)(6) BABY WITH 44% BURNS OF BOILING WATER. SKIN WAS EXTREMELY RED (MORE THAN WOULD HAVE BEEN EXPECTED). NO EXTRA TREATMENT WAS GIVEN: THE VERSAJET WAS DISCONTINUED AND ACTICOAT WAS PLACED ON THE WOUND AREA, WHICH WAS THE PLAN BEFORE THE BLISTERING HAPPENED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Blister

  MAUDE report 13013318 ↗
• MalfunctionSep 1, 2021Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT WHILE PRIMING THE VERSAJET EXACT ASSY, 45 DEGREE X 8MM WITH NORMAL SALINE, THE TUBING DEVELOPED A HOLE AND DEVICE BEGAN TO SMOKE. 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 12410313 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT A VERSAJET EXACT ASSY, 45 DEGREE X 8MM EXPLODED WHEN THE SURGEON ACTIVATED THE FOOT PEDAL. FAILURE HAPPENED DURING A SKIN GRAFT PROCEDURE. NO HARM REPORTED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041888 ↗
• MalfunctionJun 3, 2021No Flow; No Flow

  IT WAS REPORTED THAT, DURING A WOUND DEBRIDEMENT SURGERY, NO WATER FLOW WAS NOTICED THROUGH THE TIP OF A VERSAJET EXACT ASSY, 45 DEGREE X 8MM HANDPIECE; INSTEAD, IT WAS NOTICED TO FLOW THROUGH THE WASTE LIQUID TUBE. NO DELAY IN SURGERY WAS REPORTED AS A SMITH AND NEPHEW BACKUP HANDPIECE WAS AVAILABLE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11933517 ↗
• MalfunctionMay 27, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT, DURING SET UP FOR TREATMENT, THE VERSAJET II EXACT DISPOSABLE HANDPIECE 45 DEGREE X 8MM PRIMED NORMALLY, BUT NO WATER CAME OUT. THE TREATMENT WAS COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME DEVICE. PATIENT WAS NOT HARMED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892751 ↗
• MalfunctionMay 27, 2021Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT, DURING USE, A VERSAJET EXACT ASSY, 45 DEGREE X 8MM DON´T PRIMED. THE DEBRIDEMENT WAS COMPLETED WITHOUT A SIGNIFICANT DELAY USING A SMITH & NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892746 ↗
• MalfunctionMay 27, 2021Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT, DURING USE, A VERSAJET EXACT ASSY, 45 DEGREE X 8MM DON´T PRIMED. THE DEBRIDEMENT WAS COMPLETED WITHOUT A SIGNIFICANT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892743 ↗
• MalfunctionMay 27, 2021Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT, DURING TREATMENT, TWO VERSAJET EXACT ASSY, 45 DEGREE X 8MM DID NOT PRIMED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE AND WITHOUT A SIGNIFICANT DELAY. PATIENT WAS NOT HARMED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892737 ↗
• MalfunctionMay 27, 2021Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT, DURING TREATMENT, A VERSAJET EXACT ASSY, 45 DEGREE X 8MM DID NOT PRIMED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE AND WITHOUT A SIGNIFICANT DELAY. PATIENT WAS NOT HARMED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892736 ↗
• MalfunctionMay 27, 2021Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT, DURING TREATMENT, TWO VERSAJET EXACT ASSY, 45 DEGREE X 8MM DID NOT PRIMED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE AND WITHOUT A SIGNIFICANT DELAY. PATIENT WAS NOT HARMED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892734 ↗
• MalfunctionMay 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, THE TIP OF A VERSAJET EXACT ASSY, 45 DEGREE X 8MM WAS BENT AND WATER WAS A MIST INSTEAD OF JET STREAM. AS THIS WAS NOTICED ON SERVICE AND REPAIR OPERATIONS, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864167 ↗
• MalfunctionMay 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, THE TIP OF A VERSAJET EXACT ASSY, 45 DEGREE X 8MM WAS BENT AND WATER WAS A MIST INSTEAD OF JET STREAM. AS THIS WAS NOTICED ON SERVICE AND REPAIR OPERATIONS, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864138 ↗
• MalfunctionApr 23, 2021Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT A VERSAJET EXACT ASSY, 45 DEGREE X 8MM, THE HANDPIECE DIDN´T HAVE PRESSURE. THE FLOW WAS NOT A ONE SOLID STREAM. THE INSPECTION WAS COMPLETE USING A S+N BACK-UP DEVICE. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713375 ↗
• MalfunctionApr 21, 2021Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT DURING SET UP THE CONSOLE WAS NOT ABLE TO PRIME. ANOTHER SMITH & NEPHEW DEVICE WAS USED TO CONTINUE WITH THE TREATMENT. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704249 ↗
• MalfunctionApr 21, 2021No Flow; No Flow

  IT WAS REPORTED THAT DURING SET-UP THE VERSAJET II HANDPIECE PRIMED NORMALLY, BUT NO WATER CAME OUT. PROCEDURE WAS COMPLETED WITH SAME DEVICE WITH A SMALL DELAY. NO CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704241 ↗
• MalfunctionFeb 24, 2021Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT DURING TREATMENT A CABLE CAME LOOSE WITH A HIGH PRESSURE LEAK. THE CANISTERS (JAR) USED TO COLLECT THE WATER AND DEBRIS RESIDUE HAS MULTIPLE VALVES, THE USER FORGOT TO OPEN THE VALVES, SO A VACUUM WAS CREATED. THE FORCE CREATED A HIGH PRESSURE LEAK. THERE WAS A DELAY GREATER THAN 30 MINUTES, BACKUP WAS AVAILABLE AND USED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376285 ↗
• MalfunctionFeb 19, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT, DURING THE PREPARATION OF DEBRIDEMENT UTILIZING A VERSAJET, NO WATER FLOWED FROM THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347762 ↗
• MalfunctionJan 28, 2021Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT THE VERSAJET HANDPIECE WOULD NOT PRIME. NO PATIENT WAS INVOLVED. 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 11243789 ↗