VersajetRecalls & reported problems across all models
Smith & Nephew Medical Limited · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 294
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls
- 0
We found 7 models of Versajet by Smith & Nephew Medical Limited in the FDA's device registry (GUDID). Together they are named in 294 adverse event reports in the FDA's MAUDE database, received between Apr 30, 2020 and May 28, 2026 — classified as 41 injuries, 253 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Versajet problems
Device problems
- Connection Problem25
- Failure to Prime24
- No Flow23
- Difficult to Insert21
- Improper Flow or Infusion21
- Failure to Power Up18
- Overheating of Device15
- Fluid/Blood Leak13
Patient problems
- No Clinical Signs, Symptoms or Conditions272
- No Consequences Or Impact To Patient23
- No Patient Involvement8
- Insufficient Information7
- No Known Impact Or Consequence To Patient7
- No Code Available2
- Blister1
- Burn(s)1
Versajet models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Versajet 66800039Lavage, Jet160 reports
- Versajet 66800041Lavage, Jet78 reports
- Versajet 66800042Lavage, Jet33 reports
- Versajet 66800040Lavage, Jet10 reports
- Versajet 66800044Lavage, Jet8 reports
- Versajet 66800045Lavage, Jet3 reports
- Versajet 66800472Lavage, Jet2 reports
Recent Versajet adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT, DURING A DEBRIDEMENT, THE PUMP CARTRIDGE (METAL TIP WITH ORANGE HANDLE) OF A VERSAJET PLUS ASSY, 45 DEGREE X 14MM, SHOOT OUT OF THE CONSOLE PORT, DUE TO LACK OF TIGHTNESS OF THE SEAL. THIS OCCURRED ON A NEW REPLACED CONSOLE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, BY CHANGING TO SURGICAL TECHNIQUES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19596283 ↗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 ↗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 ↗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 ↗
Other Smith & Nephew Medical Limited products
All Smith & Nephew Medical Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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