Versajet 66800045Recalls & reported problems
Smith & Nephew Medical Limited · Versajet II Hydrosurgery System Handset, 45deg 8mm PLUS · Class 2
All models of Versajet (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00040565124780), received between Feb 9, 2022 and May 28, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
- Explosion1
- Material Rupture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2026
VERSAJET MACHINE FAULT LIGHT ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25315960 ↗InjuryApr 3, 2023Material Separation; Explosion; Material Separation; Explosion
IT WAS REPORTED THAT, DURING A LAVAGE PROCEDURE, WHILE USING A VERSAJET PLUS ASSY, 45 DEGREE X 8MM, A PROBLEM OCCURRED WITH THE CABLE THAT CONNECTS THE PIECE TO THE CONSOLE ITSELF. THE DEVICE BEGAN TO BE USED NORMALLY, BUT AFTER FIVE (5) MINUTES OF USE THE CABLE THAT CONNECTS THE HANDPIECE TO THE CONSOLE EXPLODED. THE CONSOLE WAS NOT DAMAGED AND CONTINUES TO WORK PERFECTLY. IT WAS IMPOSSIBLE TO CONTINUE USING THE DEVICE, SO THE SURGERY HAD TO BE SUSPENDED. NO INJURIES WERE REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16668647 ↗MalfunctionFeb 9, 2022Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture
IT WAS REPORTED THAT, DURING THE SET UP FOR A DEBRIDEMENT TREATMENT, THE WATER HOSE OF A VERSAJET II HYDROSURGERY SYSTEM HANDSET, 45DEG 8MM PLUS BURST AT THE TRANSITION TO THE HANDPIECE. TREATMENT 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 13501815 ↗
Other Lavage, Jet devices
- Elefant ASP185Coloplast A/S · LAVAGE, JET260 reports
- PULSAVAC® 00-5150-475-01Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET255 reports
- PULSAVAC® 00-5150-482-00Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET197 reports
- PULSAVAC® 00-5150-475-00Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET164 reports
- Versajet 66800039Smith & Nephew Medical Limited · Lavage, Jet160 reports
- PULSAVAC® 00-5150-482-01Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET154 reports
- Surgiphor 910110Carefusion 2200, Inc · LAVAGE, JET140 reports
- Axius Blower/Mister CB-1000Maquet Cardiovascular LLC · Lavage, Jet1 recall43 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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