MICROTEK 1 (UDI 00748426046362)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00748426046362), received between Oct 21, 2019 and Jan 16, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A STERILE INTRAOPERATIVE PROBE COVER TORE DURING SETUP IN THE OPERATING ROOM. THE TEAR OCCURRED AT THE MID COVER AREA SURROUNDING THE ULTRASOUND PROBE. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097695 ↗
• MalfunctionAug 28, 2025Separation Problem; Separation Problem

  A CUSTOMER REPORTED THAT THE PRODUCT BROKE IMMEDIATELY PRIOR TO USE. SPECIFICALLY, THE PROBE TIP DETACHED FROM THE DRAPE. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916517 ↗
• MalfunctionApr 25, 2024Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  IT WAS REPORTED THAT "FOR THE PAST FEW MONTHS, THE INTRAOPERATIVE PROBE COVER DRAPE REFERENCE (B)(4) HAS BEEN CONTINUOUSLY VERY EASILY BREAKING THROUGH CAUSING CONTAMINATION WHEN WE PLEASE THE PROBE INTO THE STERILE COVER. PLEASE SEE PICTURES ATTACHED." THE PART SHOWN BROKEN IN THE PROVIDED PICTURE IS THE TIP OF THE PROBE COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187719 ↗
• MalfunctionMar 23, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS A BUBBLE ON THE END OF THE PROBE COVER WHICH CAUSES A BLANK SPOT ON THE ULTRASOUND. NO PATIENT INJURY, INFECTION, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600150 ↗
• MalfunctionJan 13, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PROBE BROKE THROUGH THE PROBE COVER DURING SURGERY. NO PATIENT INFECTION, INJURY, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158548 ↗
• MalfunctionMar 18, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PROBE COVER BROKE AND CONTAMINATED A STENT WHILE THE PROBE WAS BEING USED TO CHECK STENT PLACEMENT. THE STENT WAS THEN REMOVED FROM THE PATIENT. THE AREA AND INSTRUMENTS WERE CLEANED AND A NEW STENT WAS PLACED. NO PATIENT INFECTION, INJURY, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13806216 ↗
• MalfunctionOct 27, 2021Break; Contamination

  VASCULAR LAB PROBE WAS BEING USED TO CHECK CAROTID STENT PLACEMENT, PROBE COVER BROKE AND CONTAMINATED STENT. STENT WAS REMOVED FROM PATIENT, CONTAMINATED ITEMS REMOVED FROM FIELD. AREA AND INSTRUMENTS CLEANED WITH BETADINE PAINT. NEW STENT OPENED AND PLACED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12711426 ↗
• MalfunctionDec 6, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A CAROTID ENDARTERECTOMY PROCEDURE, THE PROBE COVER PERFORATED AT THE TIP. THIS RESULTED IN AN UNSTERILE DOPPLER COMING INTO CONTACT WITH THE SURGICAL SITE. A SMALL CIRCULAR PIECE OF RUBBER DISLODGED FROM THE COVER AND ENDED UP IN THE PATIENTS' CAROTID ARTERY. THE PIECE WAS RETRIEVED. NO FURTHER PATIENT COMPLICATIONS WERE HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9433675 ↗
• MalfunctionOct 21, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER A PROCEDURE, A HOLE WAS DISCOVERED IN THE TOP OF THE ULTRASOUND PROBE COVER. THIS LEFT THE PROBE COVER EXPOSED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9216011 ↗