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MICROTEK 1 (UDI 00748426105991)Recalls & reported problems

Microtek Medical LLC · ANGIO DRAPE - FEMORAL/RADIAL, 1-EACH · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00748426105991), received between Jun 1, 2021 and Jun 4, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination 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

Device problems

  • Contamination /Decontamination Problem1
  • Material Discolored1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 4, 2021Material Discolored

    BROWN SPOTS ON ECOLAB-MICROTEK DRAPE. NO HARM TO PATIENT, NO CASE DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11940904 ↗
  • MalfunctionJun 1, 2021Contamination /Decontamination Problem

    BROWN SPOTS ON ECOLAB-MICROTEK DRAPE. NO HARM TO PATIENT, NO CASE DELAY. FILING MDR DUE TO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11916740 ↗

Other Drape, surgical devices

All Drape, surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.