AquamantysRecalls & reported problems across all models
Medtronic Navigation, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 12 models of Aquamantys by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Oct 15, 2019 and Sep 8, 2026 — classified as 4 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Break” (13 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 Aquamantys problems
Device problems
- Break13
- Device Damaged Prior to Use11
- Excess Flow or Over-Infusion7
- No Device Output6
- Fire5
- Failure to Shut Off4
- Activation Problem2
- Device Contamination with Chemical or Other Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient4
- Burn(s)2
- Hemorrhage/Blood Loss/Bleeding2
- Insufficient Information1
- Unspecified Infection1
Aquamantys models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Aquamantys™ 23-112-1Electrosurgical, cutting & coagulation & accessories15 reports
- Aquamantys™ 23-113-1Electrosurgical, cutting & coagulation & accessories10 reports
- Aquamantys™ 23-313-1Electrosurgical, cutting & coagulation & accessories6 reports
- Aquamantys™ 23-317-1Electrosurgical, cutting & coagulation & accessories6 reports
- Aquamantys 23-317-1ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Aquamantys™ 23-301-1Electrosurgical, cutting & coagulation & accessories2 reports
- Aquamantys™ 23-112-1Electrosurgical, cutting & coagulation & accessories2 reports
- Aquamantys™ 23-113-1Electrosurgical, cutting & coagulation & accessories2 reports
- Aquamantys ™ 23-112-1ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Aquamantys ™ 23-301-1ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Aquamantys ™ 23-313-1ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Aquamantys™ 23-112-1Electrosurgical, cutting & coagulation & accessories1 report
Recent Aquamantys adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Mechanical Problem
Information was received from a manufacturer representative regarding a handpiece. It was reported that the packaging of a new handpiece was damaged upon arrival and sterility was compromised. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669404 ↗MalfunctionSep 2, 2026Break; Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571662 ↗MalfunctionAug 25, 2026Smoking; Noise, Audible
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a handpiece. It was reported that during an above-the-knee amputation procedure, a generator produced a loud noise during activation (other case). The generator was switched out intraoperatively, and a similar loud noise was observed with the replacement generator during activation while using the same device. A loud pump noise was also reported to be always present when the handpiece was activated. The generator was then reported to have started ¿smoking¿ while the button was pressed, and use of the device was discontinued intraoperatively after the smoking was observed. The machines were changed during the case and the device was re-primed, and the procedure was completed without further use of the device. Patient was present and unknown patient impact. Additional Information was received. It was reported that the generator would not pump fluid. The cause of the noise was the bad tubing of the handpiece. The handpiece was not stopped immediately after the noise was heard; use continued until it started smoking. The noise continued during use and activation, not just during initial
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50433970 ↗MalfunctionAug 14, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50250500 ↗MalfunctionAug 11, 2026Break; Mechanical Problem; No Device Output
Information was received from a manufacturer representative regarding a handpiece. It was reported that the saline connection tube of the handpiece was torn while setting up the device before use. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208546 ↗MalfunctionMar 17, 2026Break
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A SURGICAL OF 3-4 MINUTES TO GET REPLACEMENT AND NO REPORTED IMPACT ON PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24615165 ↗MalfunctionDec 22, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT THE WATER WAS COMING OUT OF THE HAND PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23861654 ↗MalfunctionOct 22, 2025Break; Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THERE WAS A HOLE IN THE SALINE TUBING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357640 ↗MalfunctionOct 17, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE HANDPIECE TUBING WAS FOUND TO HAVE A MATERIAL PUNCTURE OR HOLE, RESULTING IN THE DEVICE DRIPPING ONTO THE FLOOR. THE IRRIGATION FROM THE BAG HAD BEEN USED TO IRRIGATE AN INTEGRA PATCH FOR IMPLANTATION. THERE WAS NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322358 ↗MalfunctionSep 4, 2025Activation Problem; Activation Problem
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THE HANDPIECE BUTTON WAS NOT WORKING. A NEW HANDPIECE WAS BROUGHT IN, AND IT FUNCTIONED AS DESIGNED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INCIDENT HAPPENED AT THE START OF THE CASE. PATIENT WAS PRESENT AND THE CASE WAS DELAYED SLIGHTLY TO REPLACE WITH NEW HANDPIECE AND IT WAS REPORTED THAT THE PROCEDURE PERFORMED AT THE TIME OF EVENT OCCURRED WAS A SPINE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963556 ↗MalfunctionAug 26, 2025Failure to Prime; Obstruction of Flow; Failure to Prime; Obstruction of Flow
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE HANDPIECE FAILED TO PRIME AND THERE WAS NO SALINE FLOW IN TUBING. INITIALLY TUBING WAS PLACED INTO THE PUMP SEGMENT AND THE PRIME BUTTON WAS PRESSED. THE PUMP SEGMENT ROLLERS WERE AUDIBLY TURNING INSIDE BUT THERE WAS NO FLUID MOVEMENT. THE PRIME FEATURE WAS STOPPED AND THE TUBING WAS REMOVED FROM THE PUMP. TROUBLESHOOTING METHODS WERE PERFORMED WITH TUBING REMOVED AND PRIME BUTTON PRESSED BRIEFLY WITH THE PUMP SEGMENT OPEN TO VISUALLY INSPECT MOVEMENT OF THE ROLLERS (NO ISSUE NOTED), THE IV BAG WAS SQUEEZED BUT NO FLUID WAS PASSING THROUGH THE TUBING, A NEW 1000ML BAG OF SALINE WAS SPIKED AND THE DRIP CHAMBER WAS SQUEEZED BUT DID NOT MOVE FLUID DOWN THE TUBING, A FINAL ATTEMPT WAS MADE BY PLACING THE TUBING BACK INTO THE PUMP SEGMENT BUT THE TUBING WOULD NOT PRIME OR DELIVER FLUID TO THE TIP OF THE DEVICE. FAILED TO RESOLE THE ISSUE AFTER MULTIPLE ATTEMPTS. A NEW HANDPIECE WAS DELIVERED TO THE STERILE FIELD AND THEN CONNECTED TO THE AEX GENERATOR, IT WORKED WITHOUT ISSUE. NO REPORTED IMPACT ON PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22892147 ↗MalfunctionAug 26, 2025Break; Break
IT IS REPORTED THAT WHILE PREPARING FOR A PROCEDURE THERE WAS A CRACK IN THE TUBE THAT CAUSED SALINE TO LEAK. NO PATIENT CAME IN CONTACT WITH DEVICE AND THERE WAS NO REPORTED IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22892059 ↗MalfunctionJul 28, 2025Energy Output Problem; Energy Output Problem
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A GENERATOR. IT WAS REPORTED THAT THE HANDPIECE COULDN'T STOP BLEEDING DURING A PROCEDURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22629634 ↗MalfunctionJul 17, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE HANDPIECE IRRIGATION LINE WAS TORN OUT. ISSUE OCCURRED PRE-OPERATIVELY AND THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22528540 ↗MalfunctionJul 16, 2025Material Puncture/Hole
DURING THE CASE, IT WAS DISCOVERED THAT THE AQUAMANTYS TUBING HAD A HOLE IN THE LINE. THE AQUAMANTYS WAS DRIPPING ONTO THE FLOOR AND THE IRRIGATION FROM THE BAG HAD BEEN USED TO IRRIGATE AN INTEGRA PATCH FOR IMPLANTATION. THE TUBING WAS NOT SAVED AFTER THE PROCEDURE AND THE OR MANAGER SUBMITTED A TICKET FOR BIOMED DEPT INVESTIGATION OF THE AQUAMANTYS MACHINE AS THE HOLE IN TUBING WAS WITHIN THE MACHINE ITSELF - PENDING FEEDBACK FROM BIOMED DEPT. AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22518725 ↗
Other Medtronic Navigation, Inc. products
- O-ARM17 models · 9,235 reports · 5 recalls
- StealthStation S8 Platform14 models · 8,402 reports
- Stealthstation S711 models · 5,756 reports
- StealthStation S86 models · 2,235 reports
- Fusion ENT Image Guidance System5 models · 2,033 reports
- Visualase25 models · 625 reports · 3 recalls
- NavLock9 models · 134 reports · 1 recall
- AxiEM12 models · 62 reports · 2 recalls
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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