NA 1120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734400176), received between Jun 18, 2018 and Jun 10, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2023Break; Break

  DURING A IMPLANT PROCEDURE ON (B)(6) 2023 THE TUNNELING TOOL SHEATH WAS BUNCHED UP DAMAGED AND SPLIT WHILE IN USE. AS SUCH, THE PHYSICIAN MADE AN INCISION TO REMOVE THE PIECES THAT WERE STUCK INSIDE OF THE PATIENT. ALL BROKEN PIECES WERE REMOVED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101909 ↗
• InjuryJun 18, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE LEAD REVISION PROCEDURE THE PATIENTS BREATHING PATTERN CHANGED. THERE WAS BLOOD FOUNDED IN THE RESPIRATORY TUBE. PHYSICIAN BELIEVED HE REACHED THE PATIENT'S LUNGS WITH THE TUNNELING TOOL. NO ABNORMALITIES WERE FOUND THROUGH DIAGNOSTIC TESTS. IN TURN, THE PATIENT STAYED THE NIGHT IN THE ICU FOR OBSERVATION. REPORTEDLY, THE ISSUE WAS RESOLVED AND EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Respiratory Distress

  MAUDE report 7612185 ↗