TEG5000 HEMOSTASIS ANALYZER 07-022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30812747018184), received between Jan 28, 2020 and May 18, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 19, 2022Class IITerminated

   When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.

   Z-1298-2022 · Root cause: Software design · Recall details · FDA record ↗

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.

• MalfunctionMay 18, 2021Temperature Problem; Temperature Problem

  HAEMONETICS WAS NOTIFIED THAT A CUSTOMER REPORTED A TEG DEVICE IS EMITTING SMOKE FROM WHERE CHANNELS ARE CONNECTED, CUSTOMER NEEDS FSE FOR REPAIR AND THIS WAS HAPPENED AFTER THE PM HAS DONE ON THAT DEVICE. THERE WAS NO DONOR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11843483 ↗
• MalfunctionJan 28, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  ON (B)(6) 2019 HAEMONETICS WAS INFORMED THAT DURING A QUALITY CHECK (QC) A TEG ANALYZR, 5000, 60HZ, FG STARTED SMOKING AND TURNED ITSELF OFF. THE ANALYZER WAS THEN UNPLUGGED. A PATIENT WAS NOT AT THE TIME THE EVENT OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 9636263 ↗