MICROTEK 1 (UDI 00748426047864)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00748426047864), received between Sep 14, 2017 and Jan 5, 2023 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE PROBE COVER. NO PATIENT INFECTION, INJURY, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16103372 ↗
• MalfunctionMar 17, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT TWO PROBE COVERS RIPPED AND BECAME CONTAMINATED. NO PATIENT HARM/INFECTION OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11503795 ↗
• InjuryJul 1, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS FURTHER REPORTED THAT A PROBE PIN HOLE WAS SUSPECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8749666 ↗
• InjuryJun 3, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS FURTHER REPORTED THAT A PROBE PIN HOLE WAS SUSPECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8662787 ↗
• InjuryJun 3, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS FURTHER REPORTED THAT A PROBE PIN HOLE WAS SUSPECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8662718 ↗
• InjuryMay 31, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ONE DAY AFTER A PROCEDURE, A PORT PLACEMENT PATIENT RETURNED WITH AN INFECTED PORT AFTER THE USE OF A PROBE COVER. THE MANUFACTURE OF THE PROBE COVER WAS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8660199 ↗
• MalfunctionMay 31, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PROCEDURE, A TIN PIN LIKE HOLE WAS OBSERVED IN THE PLASTIC WHEN THE GEL WAS PLACED IN THE PROBE COVER. THE PROBE COVER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8659982 ↗
• MalfunctionSep 14, 2017Hole In Material; Material Rupture; Hole In Material; Material Rupture

  END USER REPORTED A QUALITY ISSUE WITH THE INTRAOPERATIVE PROBE COVER PC1292. THE PROBE COVER WAS RIPPED/FALLING APART. THE ISSUE WAS NOT IDENTIFIED UNTIL AFTER THE COVER HAD BEEN PASSED TO THE FIELD, REQUIRING THE STAFF TO HAVE TO TEAR DOWN THEIR STERILE FIELD AND SET IT ALL BACK UP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6865280 ↗