CLEANER Vac™ 70027518Recalls & reported problems
Argon Medical Devices, Inc. · CLEANER Vac™ Thrombectomy System - 18F OD x 115cm · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333227167), received between Jan 16, 2026 and Jan 16, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2026Fracture
AN ASPIRATION THROMBECTOMY PROCEDURE WAS PERFORMED ON A 31-YEAR-OLD MALE PATIENT WITH ILIOFEMORAL DEEP VEIN THROMBOSIS. POPLITEAL ACCESS WITH MEDTRONIC 20F SENTRANT INTRODUCER, USE OF AEANER VAC SYSTEM, FINDING CALCIFICATION IN THE PROXIMAL SEGMENT OF THE SEGMENT TO BE TREATED AND AN ACUTE THROMBUS OF 4 DAYS' EVOLUTION THE DISTAL SEGMENT, LIOFEMORAL REGION. THE CATHETER SUFFERS MULTIPLE DAMAGES BOTH AT THE TIP AND TWISTING OF THE OTHER DISTAL BODY OF THE ASPIRATION CATHETER. IN THE LAST ATTEMPT TO ASPIRATE. THE TRACKABILITY DILATOR FRACTURED. SO THE PROCEDURE COULD NOT BE COMPLETED WITH 100% SUCCESS.
Patient problems: Insufficient Information
MAUDE report 24100958 ↗
Other Peripheral Mechanical Thrombectomy With Aspiration devices
- Indigo System LITNG12HTORQ115-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration4 deaths105 reports
- Indigo System LITNG7XTORQ130-APenumbra, Inc. · Peripheral mechanical thrombectomy with aspiration100 reports
- Indigo System LITNG12XTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death80 reports
- ClotTriever XL Catheter AS-0235Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 recall9 deaths20 reports
- Indigo System LITNG12HTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death46 reports
- Indigo System LITNGBT7TQ130-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration46 reports
- Triever 24 22-101Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration20 deaths34 reports
- ClotTriever Catheter, 16 mm 40-102Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration11 deaths27 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.