N/A (REF BD710DF282CT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841898123290), received between Nov 23, 2021 and Nov 29, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 29, 2022Device Reprocessing Problem; Device Reprocessing Problem

  THE DEVICE WAS REPORTED TO HAVE FIBROUS MATERIAL ON THE DISTAL TIP. NO PATIENT INJURIES WERE REPORTED. THE MATERIAL WAS IDENTIFIED DURING THE PROCEDURE, BEFORE THE CATHETER WAS USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882757 ↗
• MalfunctionNov 18, 2022Device Reprocessing Problem; Device Reprocessing Problem

  THIS DEVICE WAS IDENTIFIED IN A COMPLAINT BIN AT THE CUSTOMER SITE BY AN INNOVATIVE HEALTH EMPLOYEE. NO INFORMATION WAS PROVIDED REGARDING THE EVENT. IT IS UNKNOWN WHEN THE ISSUE OCCURRED AND WHEN IT WAS IDENTIFIED. UPON INSPECTING THE COMPLAINT DEVICE, FOREIGN MATERIAL WAS IDENTIFIED ON THE TIP OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829528 ↗
• MalfunctionNov 23, 2021Device Reprocessing Problem; Device Reprocessing Problem

  THIS DEVICE REPORTEDLY HAD FOREIGN MATERIAL AT THE END OF THE CATHETER TIP. THIS WAS NOTICED BEFORE USE DURING THE PROEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861396 ↗