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MICROTEK 1 (UDI 00748426036233)Recalls & reported problems

Microtek Medical LLC · STANDARD COMFORT LINED SLEEVES, (25 PAIR), 1-EACH · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00748426036233), received between Dec 6, 2018 and Dec 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Pressure 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

  • Pressure Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 6, 2018Pressure Problem; Pressure Problem

    IT WAS REPORTED THAT DURING MULTIPLE USES, THE ALARM SYSTEM WOULD CONTINUALLY SOUND OFF. IT WAS NOTED THAT THIS HAS OCCURED DURING SURGERIES AND THE COMPRESSION SYSTEM OR SLEEVES CANNOT BE REPLACED. THE SURGERIES WERE CONTINUED WITHOUT THERAPY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8137428 ↗

Other SLEEVE, LIMB, COMPRESSIBLE devices

All SLEEVE, LIMB, COMPRESSIBLE devices →

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