Versajet 66800040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00040565124674), received between Oct 20, 2020 and Dec 6, 2022 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “No Flow” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE VERSAJET EXACT ASSY, 15 DEGREE X 14MM DEVICE WAS FOUND TO BE LEAKING. THE PROCEDURE WAS CANCELLED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923636 ↗
• MalfunctionMay 5, 2022Leak/Splash; Improper Flow or Infusion; Material Twisted/Bent; Leak/Splash; Improper Flow or Infusion; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING DEBRIDEMENT SURGERY, THE BENDING PART OF A VERSAJET HANDPIECE DID NOT MATCH, FOR WHICH WATER SPLASHED IN ALL DIRECTIONS. SURGERY WAS RESUMED, AFTER A SIGNIFICANT DELAY GREATER THAN 30 MIN, 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 14290067 ↗
• MalfunctionMar 17, 2022Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING DEBRIDEMENT, THE CONNECTING TUBE OF THE VERSAJET EXACT ASSY FELL OFF. PROCEDURE WAS RESUMED, AFTER A +31 MINUTES DELAY, USING A BACK UP DEVICE. NO OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13791337 ↗
• MalfunctionApr 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE WATER LINE FOR TISSUE DEBRIDEMENT WAS NOT COME OUT AS USUAL FROM THE VERSAJET EXACT ASSY, 15 DEGREE X 14MM. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711303 ↗
• MalfunctionApr 2, 2021No Flow; No Flow

  IT WAS REPORTED THAT DURING DEBRIDEMENT, SALINE WOULD NOT COME OUT. PROCEDURE WAS COMPLETED WITH SAME DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611266 ↗
• MalfunctionMar 16, 2021No Flow; No Flow

  IT WAS REPORTED THAT, DURING FOOT AND ANKLE SURGERY, VERSAJET II DEVICE WATER STOPED FLOWING OUT WHILE USING THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11492164 ↗
• MalfunctionJan 13, 2021No Flow; No Flow

  IT WAS REPORTED THAT DURING THE DEBRIDEMENT OF BURNS THE SALINE COULD NOT BE DRAINED WHEN THE HANDPIECE WAS CONNECTED. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167474 ↗
• MalfunctionDec 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT, THE VERSAJET HANDPIECE LINE WAS LEAKING OUT OF THE ADAPTER. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. 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 11030268 ↗
• MalfunctionOct 23, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE HOSE WAS DETACHED DURING USE. 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 10726068 ↗
• InjuryOct 20, 2020Failure to Prime; No Flow; Failure to Prime; No Flow

  IT WAS REPORTED THAT THE VERSAJET HANDPIECE FAILED TO PRIME DURING USE. THE TREATMENT CONTINUED WITH A BACK-UP DEVICE WITH A SMALL DELAY. AN INJURY WAS REPORTED BUT FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10708803 ↗