HemosIL AcuStar 0009801000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08426950498001), received between Feb 5, 2019 and Feb 5, 2019 — classified as 1 death.

The most frequently reported specific device problem is “False Positive Result” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• DeathFeb 5, 2019False Positive Result; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT TWO PREGNANT PATIENTS WERE DIAGNOSED WITH ANTIPHOSPHOLIPID SYNDROME BASED ON A POSITIVE ANTI-CARDIOLIPIN IGG (ACL IGG) RESULTS ON THE ACL ACUSTAR AND SUBSEQUENTLY TREATED WITH LOW MOLECULAR WEIGHT HEPARIN AND ACETYLSALICYLIC ACID/ASPIRIN. DURING THEIR PREGNANCY, EACH WOMAN DEVELOPED A UTERINE HEMATOMA. ANTICOAGULATION THERAPY WAS STOPPED AFTER HEMATOMAS OCCURRED. ADDITIONALLY, ONE OF THE PATIENTS ALSO EXPERIENCED A SPONTANEOUS ABORTION AT 7-8 WEEKS OF GESTATION; HOWEVER, THE CUSTOMER INDICATED THAT IT WAS NOT POSSIBLE TO DEFINITELY DETERMINE THE UNDERLYING CAUSE OF THE ABORTED PREGNANCY, AS SHE WAS A HIGH-RISK PATIENT WITH PREVIOUS MISCARRIAGES.

  Patient problems: Miscarriage

  MAUDE report 8305305 ↗