Arthrex® ABS-10020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867001879), received between Jul 18, 2023 and Jul 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2023No Device Output; Obstruction of Flow; No Device Output; Obstruction of Flow

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10020 CENTRIFUGE DID NOT OUTPUT ANY BLOOD. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17380127 ↗
• MalfunctionJul 18, 2023Infusion or Flow Problem; Infusion or Flow Problem

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10020 ANGEL UNIT STRUGGLES TO PULL UP THE BLOOD OR BMA FROM THE WHOLE BLOOD IN THE BAG AND THEN THE ALARM GOES OFF. THE CASE WAS COMPLETED, THEY HIT THE PROCESS BUTTON AS MUCH AS NEEDED AND IT EVENTUALLY GETS THE BLOOD PULLED UP, BUT IT REALLY SEEMS TO STRUGGLE DURING THE PROCESS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343643 ↗