Tunneler 5688000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741085475), received between Nov 16, 2018 and Jul 24, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionJul 24, 2019Defective Component; Defective Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5688000 TUNNELER ALLEGEDLY EXPERIENCED THE WHITE PLASTIC BEING CRUMPLED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822396 ↗
• MalfunctionJan 3, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE TUNNELER COMPONENT ALLEGEDLY CRACKED WHILE ADVANCING INTO THE PATIENT TRACT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8215023 ↗
• MalfunctionNov 16, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT WHILE INSERTING THE DEVICE, THE WHITE PLASTIC SLEEVE SPLIT AND CAME OFF THE METAL TUNNELER. IT WAS FURTHER REPORTED THAT THE WHITE PLASTIC SLEEVE AND CATHETER WERE STUCK IN THE PATIENT, WHERE THE PHYSICIAN WAS ABLE TO PULL THE SLEEVE AND THE CATHETER OUT IN A SINGLE UNIT. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8078018 ↗