AMERICAN BIOSURGICAL AB 1000-C-NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10852028007021), received between May 28, 2021 and May 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• MalfunctionMay 28, 2021Insufficient Device Problem Information

  THE PATIENT HAS A PACEMAKER SO THE BIPOLAR SHOULD NOT INTERFERE WITH ITS FUNCTION. WHEN THE SURGEON USED THE BIPOLAR, THE PATIENT STARTED HAVING ARRHYTHMIAS. THE SURGEON DISCONTINUED USING IT, SWITCHED TO A DIFFERENT BIPOLAR CORD AND NO FURTHER ARRHYTHMIAS WERE NOTED. WE ARE NOT SURE IF THE CORD WAS RESPONSIBLE, BUT IT IS SUSPICIOUS.

  Patient problems: Arrhythmia

  MAUDE report 11903185 ↗