MICROTEK 1 (UDI 00748426107384)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00748426107384), received between Nov 15, 2023 and Aug 21, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT IN TOTAL 177 PIECES FROM LOT 3253LR5700 WERE AFFECTED BY THE FOLLOWING CONDIITION: WHEN INSTALLING THE PROTECTION ON THE PROBE, THE PART OF THE END OF THE COVER THAT IS SUPPOSED TO STICK TO THE PROBE DOES NOT STICK. THE ADHESIVE REMAINS ON THE WHITE PART OF THE LABEL AND NOT ON THE COVER. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015585 ↗
• MalfunctionJul 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A MATEROVIGILANCE REPORT INDICATED THAT A CUSTOMER ENCOUNTERED THE SAME PROBLEM WITH REFERENCE (B)(4). IT WAS FROM THE SAME BATCH AS THE INCIDENT REPORTED IN APRIL COMP-(B)(4). THE ADHESIVE REMAINS ON THE LABEL INSTEAD OF ON THE PROBE COVER. TEST ON THREE DEVICES FROM THE SAME BATCH: SAME FINDING. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706508 ↗
• MalfunctionApr 3, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT WHEN INSTALLING THE PROTECTION ON THE PROBE, THE PART OF THE END OF THE COVER THAT IS SUPPOSED TO STICK TO THE PROBE DOES NOT STICK. THE ADHESIVE REMAINS ON THE WHITE PART OF THE LABEL AND NOT ON THE COVER. NO PATIENT INJURY, INFECTIOS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038710 ↗
• MalfunctionNov 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT FOUR UNITS WERE AFFECTED. THE PROBLEM WAS DETECTED BY THE NURSE BEFORE THE PROCEDURE. WHEN SEPARATING THE PROTECTIVE BARRIER THAT COVERS THE ADHESIVE, THE ADHESIVE IS DETACHING FROM THE PROBE COVER. THIS IS COMMONLY OCCURRING WITH THIS PARTICULAR LOT. THIS IS HAPPENING ON THE DISTAL TIP OF THE ADHESIVE PROBE COVER. THE ADHESIVE IS DETACHING WHEN THE PROTECTIVE COVER IS REMOVED. NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215395 ↗
• MalfunctionNov 22, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PROBE COVER ADHESIVE COMES OFF WHEN THEY TRY TO PULL OFF THE ADHESIVE COVER ON OUR APC1291 PROBE COVERS. THE ADHESIVE IS REMAINING STUCK ON THE PROBE. THIS IS HAPPENING ON THE DISTAL TIP INISIDE THE PROBE COVER; AT THE CONCLUSION OF THE CASE WHEN THEY ARE REMOVING THE PROBE FROM THE PROBE COVER. NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191025 ↗
• MalfunctionNov 15, 2023Material Perforation; Material Perforation

  IT WAS REPORTED THAT THE ADHESIVE IS EITHER STICKING TO THE REMOVABLE PART, OR THE ADHESIVE IS STICKING SO STRONG THAT IT IS RIPPING THE PROBE COVER. NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141565 ↗