MICROTEK 1 (UDI 00748426066896)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00748426066896), received between Aug 8, 2025 and Aug 8, 2025 — classified as 1 malfunction.

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

Recent adverse event reports

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

• MalfunctionAug 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A FOREIGN OBJECT, GLASS FRAGMENT, WAS EMBEDDED IN THE REAR SECTION OF THE MICROTEK PACEMAKER DRAPE (REF #PD201, LOT 4364LRO000). DURING THE DRAPING PROCESS IN THE CATHETERIZATION LABORATORY (CATH LAB), THE FRAGMENT MADE CONTACT WITH A RADIATION TECHNICIAN. THE GLASS WAS PARTIALLY PROTRUDING FROM THE FABRIC AND CAUSED A POKE TO THE TECHNICIAN. HOWEVER, THE CONTACT DID NOT RESULT IN SKIN PENETRATION, LACERATION, OR ANY REPORTABLE INJURY. THE INCIDENT WAS PROMPTLY DOCUMENTED BY THE REPORTER, AND PHOTOGRAPHIC EVIDENCE WAS COLLECTED TO SUPPORT THE COMPLAINT. NO PATIENT CONTACT OCCURRED, AND THERE WERE NO REPORTED INFECTIONS, COMPLICATIONS, OR ADVERSE CLINICAL OUTCOMES ASSOCIATED WITH THE EVENT. THE MANUFACTURER CONDUCTED AN INVESTIGATION BUT WAS UNABLE TO DETERMINE THE ORIGIN OF THE FOREIGN MATERIAL. NO ROOT CAUSE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749005 ↗