Cleaner15™ Rotational Thrombectomy System 700015Recalls & reported problems
Argon Medical Devices, Inc. · Cleaner15™ Rotational Thrombectomy System 7F x 65cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886333222315), received between Jan 13, 2021 and Dec 8, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break4
- Entrapment of Device2
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient3
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE CUSTOMER SAID THAT THIS WAS A ROUTINE FISTULA DE-CLOT HE SAID THAT NOTHING WAS OUT OF THE ORDINARY. DURING THE PROCESS OF DE-CLOTTING THE FISTULA USING THE CLEANER THE TIP OF THE DEVICE CAME OFF. THEY WERE NOT ABLE TO RETRIEVE THE PIECE FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 18292535 ↗MalfunctionJun 28, 2022Break; Entrapment of Device
HE IS TREATMENT FOR DVT AT UPPER ILIAC VEIN. HE HAS ENOUGH EXPERIENCES FOR CLEANER AND HE FOLLOWED IFU PROCEDURE STEP. THE WIRE TIP WAS APART WHEN CLEANER IS WORKING SO HE TOOK CT AND THE TIP WAS FOUND AT INFERIOR EPIGASTRIC VEIN SO HE DECIDED IT IS HARD TO REMOVE AND THE TIP WAS LEFT BEHIND DUE TO LOW RISK TO THE PATIENT. HE INFORMED A PATIENT ABOUT IT AND HE WILL CONTINUE TO MONITOR THE PATIENT¿S CONDITION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 14841950 ↗MalfunctionSep 3, 2021Break
SURGEON WAS USING ARGON CLEANER DEVICE, TIP BROKE OFF OF DEVICE INTO PATIENT. UNABLE TO RETRIEVE DISLODGED TIP. NO PATIENT COMPLICATION AT THE TIME OF SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 12425255 ↗MalfunctionJan 13, 2021Break; Entrapment of Device
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- Renegade™ HI-FLO™ Kit M001183020Boston Scientific Corporation · Catheter, continuous flush109 reports
- EkoSonic® 6779-002Boston Scientific Corporation · Catheter, Continuous Flush1 recall4 deaths56 reports
- Chameleon CH08-40-75USMozarc Medical US LLC · Catheter, continuous flush2 recalls4 reports
- RebarTM 105-5081-153Micro Therapeutics, Inc. · Catheter, continuous flush2 deaths102 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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