ENDOPATH EBF01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705036011880), received between Dec 17, 2018 and Dec 17, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2018Device Markings/Labelling Problem; Packaging Problem

  IT WAS REPORTED THAT IT WAS FOUND AT AN AGENCY THAT THE ARTICLE NUMBER ON THE PACKAGE WAS DIFFERENT FROM THAT OF THE LABEL. WHEN THE PRODUCT WAS CHECKED, IT WAS FOUND THAT THE DEVICE WAS PACKED IN A BOX OF EBF02. THE ARTICLE NUMBER ON THE LABEL, THE PRODUCT ITSELF, TYVEK AND THE BARCODE WAS EBF01. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171834 ↗
• MalfunctionDec 17, 2018Device Markings/Labelling Problem

  IT WAS REPORTED THAT IT WAS FOUND AT AN AGENCY THAT THE ARTICLE NUMBER ON THE PACKAGE WAS DIFFERENT FROM THAT OF THE LABEL. WHEN THE PRODUCT WAS CHECKED, IT WAS FOUND THAT THE DEVICE WAS PACKED IN A BOX OF EBF02. THE ARTICLE NUMBER ON THE LABEL, THE PRODUCT ITSELF, TYVEK AND THE BARCODE WAS EBF01. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171812 ↗