Cleaner XT™ Rotational Thrombectomy System 700009XTRecalls & reported problems
Argon Medical Devices, Inc. · Cleaner XT™ Rotational Thrombectomy System 6F x 65cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00886333222308), received between Sep 17, 2021 and Feb 18, 2025 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Material Twisted/Bent2
- Difficult to Remove1
- Failure to Power Up1
- Output Problem1
- Therapeutic or Diagnostic Output Failure1
- Unraveled Material1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions5
- Foreign Body In Patient1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2025Break; Break
THE TIP OF THE CLEANERXT IS BROKE DURING THE PROCEDURE. FAULTY ITEM WAS DISPOSED BY END USER AS IT WAS CONTAMINATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21400030 ↗MalfunctionDec 1, 2024Break; Break
A RISK MANAGER REPORTED A PIECE OF WIRE USED TO PERFORM FISTULAGRAM BROKE OFF AND WAS UNABLE TO BE RETRIEVED. STENT WAS PLACED AND DEVICE REPRESENTATIVE WAS CONTACTED.
Patient problems: Insufficient Information
MAUDE report 20815754 ↗MalfunctionAug 22, 2024Break; Break
REPORTER INDICATED "WHILE DEVICE WAS BEING ADVANCED THE SINUSOIDAL WIRE PERFORATED THE VESSEL AND THE SILICON TIP BROKE OFF, LEAVING PART THE SILICON TIP IN THE PATIENT'S BICEP."
Patient problems: Foreign Body In Patient
MAUDE report 20035903 ↗InjuryJul 11, 2024Break; Break
THE REPORTER INDICATED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE, THE S-WIRE OF CLEANER DEVICE BROKE OFF IN PATIENT AND HAD TO BE SNARED OUT. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 19726595 ↗MalfunctionJul 28, 2022Therapeutic or Diagnostic Output Failure
ARGON CLEANER DEVICE AND FOUND THERE WAS AN ISSUE WITH IT NOT WORKING PROPERLY SO THEY HAD TO OPEN AN ADDITIONAL ONE. THEY KEPT THE PRODUCT IN THE BOX. DR. LEE HAD INSERTED THE DEVICE IT WAS WORKING AND SPINNING PROPERLY BUT WHEN HE STARTED TO PULL THE DEVICE OUT, THE ENTIRE WIRE WAS COMING OUT AS WELL. SO THEY STOPPED TO TRY AND FIX IT BUT IT WOULD NO LONGER STAY IN THE DEVICE AND WAS NO LONGER SPINNING. AT THIS POINT THEY PUT IT ASIDE AND OPENED A NEW ONE TO CONTINUE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15123048 ↗MalfunctionJul 28, 2022Output Problem
ARGON CLEANER DEVICE AND FOUND THERE WAS AN ISSUE WITH IT NOT WORKING PROPERLY SO THEY HAD TO OPEN AN ADDITIONAL ONE. THEY KEPT THE PRODUCT IN THE BOX. DR.(B)(6) HAD INSERTED THE DEVICE IT WAS WORKING AND SPINNING PROPERLY BUT WHEN HE STARTED TO PULL THE DEVICE OUT, THE ENTIRE WIRE WAS COMING OUT AS WELL. SO THEY STOPPED TO TRY AND FIX IT BUT IT WOULD NO LONGER STAY IN THE DEVICE AND WAS NO LONGER SPINNING. AT THIS POINT THEY PUT IT ASIDE AND OPENED A NEW ONE TO CONTINUE THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 15122938 ↗MalfunctionApr 14, 2022Material Twisted/Bent
THE WIRE DID NOT ROTATE WHEN HE WAS PRESSING THE BUTTON FOR ROTATING TO TREAT AVG THROMBUS. HE TOOK IT OUT FROM AVG AND FOUND THE WIRE WAS BENT WRONG WAY. HE USED OTHER CLEANER AND FINISHED THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14111566 ↗MalfunctionFeb 14, 2022Unraveled Material
UNRAVELED, LOST SHAPE CAUGHT IN BRANCH PER CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13523715 ↗MalfunctionJan 13, 2022Difficult to Remove; Material Twisted/Bent
WHEN DEPLOYING THE CLEANER, THE SINUSOIDAL WIRE BENT AT THE TIP. THE DEVICE WAS ALSO DIFFICULT TO REMOVE AFTER ISSUE.
Patient problems: Insufficient Information
MAUDE report 13251527 ↗MalfunctionNov 24, 2021Failure to Power Up
DEVICE WAS IN THE BODY BUT DID NOT TURN ON. NO HARM WAS DONE TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12870775 ↗MalfunctionSep 17, 2021Break
TIP BROKE OFF IN A PATIENT DURING USE.
Patient problems: Insufficient Information
MAUDE report 12492574 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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