QuickClear Thrombectomy System AC10SH085Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845225003142), received between Mar 20, 2026 and Mar 20, 2026 — classified as 2 injuries.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A QUICK CLEAR DEVICE WAS USED IN A CLINICAL STUDY TO TREAT AN OCCLUSIVE DEEP VEIN THROMBOSIS (DVT) ON THE EXTERNAL ILIAC VEIN, COMMON FEMORAL VEIN, FEMORAL VEIN, AND NONOCCLUSIVE DVT LOCATED ABOVE THE KNEE IN THE POPLITEAL. HOWEVER, 2 DAYS POST INDEX PROCEDURE ON (B)(6) 2025, THE PATIENT EXPERIENCED LEFT INNER THIGH REDNESS AND PAIN WITH EXTREME PRESSURE WHILE WALKING. FOUR DAYS LATER ON (B)(6) 2025, A FOLLOW UP CALL REVEALED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED HEPARIN DRIP WITH NO OTHER INTERVENTION PERFORMED. IT WAS INDICATED THAT THIS IS POSSIBLY RELATED TO STUDY DEVICE AND POSSIBLY RELATED TO THE STUDY PROCEDURE. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE PATIENT EXPERIENCED REDNESS AND PAIN ON THE LEFT LEG, RESULTING IN HOSPITALIZATION AND INTERVENTION.

  Patient problems: Pain; Skin Discoloration

  MAUDE report 24654553 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A QUICKCLEAR DEVICE WAS USED IN A CLINICAL STUDY TO TREAT AN OCCLUSIVE DEEP VEIN THROMBOSIS (DVT) ON THE COMMON ILIAC VEIN, EXTERNAL ILIAC VEIN, COMMON FEMORAL VEIN, FEMORAL VEIN, AND A NONOCCLUSIVE DVT IN THE FEMORAL VEIN. AFTER TREATMENT, THE PATIENT WAS SENT HOME; HOWEVER, THE PATIENT EXPERIENCED SYNCOPAL EPISODE AND REQUIRED EMERGENCY CARE. THE PATIENT WAS ANEMIC WHEN SHE ARRIVED IN THE EMERGENCY ROOM (ER), THUS ADMINISTERED WITH 1 UNIT OF BLOOD AND IV FLUIDS. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION AND DISCHARGED THE FOLLOWING DAY. IT WAS THOUGHT THAT THE MOST LIKELY CAUSE FOR THE SYNCOPE EPISODE, WAS DUE TO HYPOVOLEMIA AND BLOOD LOSS ANEMIA POST INDEX PROCEDURE. THIS WAS DETERMINED TO BE DEFINITELY RELATED TO THE STUDY PROCEDURE AND POSSIBLY RELATED TO THE QUICKCLEAR DEVICE. ON (B)(6) 2023, THE PATIENT EXPERIENCED ANOTHER SYNCOPAL EPISODE AND RETURNED TO THE ER FOR TREATMENT. A CT SCAN SHOWED "FLUID COLLECTION WITHIN SEMI MEMBRANOUS MUSCLE BELLY AND INCLUDING THE ADDUCTOR MUSCLE GROUPS LIKELY CONSISTENT WITH AN AGE-INDETERMINATE HEMATOMA WITHOUT EVIDENCE OF ACTIVE EXTRAVASATION". THE PATIENT WAS GIVEN 2 UNITS OF PACKED RED BLOOD CELLS (PRBC) TO TREAT AN

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Hypovolemia

  MAUDE report 24654254 ↗