NC TREK 1012444-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648151583), received between Aug 28, 2020 and Aug 28, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A 1.50X8MM NC TREK BALLOON (1012444-08 / 71117G1) WAS RETURNED UNUSED FROM THE HOSPITAL. THE ADDENDUM LABEL CONTENT [1012448-08] WAS DISCREPANT FROM THE ORIGINAL LABEL CONTENT [1012444-08]. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10468995 ↗
• MalfunctionAug 28, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A 1.50X8MM NC TREK BALLOON (1012444-08/71117G1) WAS RETURNED UNUSED FROM THE HOSPITAL. THE ADDENDUM LABEL CONTENT [(B)(4)] WAS DISCREPANT FROM THE ORIGINAL LABEL CONTENT [(B)(4)]. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10468934 ↗
• MalfunctionAug 28, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A 1.50X8MM NC TREK BALLOON (1012444-08 / 71117G1) WAS RETURNED UNUSED FROM THE HOSPITAL. THE ADDENDUM LABEL CONTENT [(B)(4)] WAS DISCREPANT FROM THE ORIGINAL LABEL CONTENT [(B)(4)]. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10468911 ↗