QuickClear Thrombectomy System AC8SH085Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845225003128), received between Oct 6, 2021 and Oct 6, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE, THE TIP OF THE QUICKCLEAR PARTIALLY SEPARATED WHILE INSIDE THE PATIENT, BUT DID NOT FULLY DETACH INTO TWO PIECES. THE DEVICE WAS ABLE TO BE REMOVED ALONE AND THE WIRE AND SHEATH REMAINED. THERE WAS NO RESISTANCE NOTED DURING DELIVERY OR RETRACTION. A NEW QUICKCLEAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE TIP OF THE QUICKCLEAR DEVICE PARTIALLY SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584724 ↗