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NA 26018Recalls & reported problems

Atrium Medical Corporation · TUNNELER, 4MM/TIPS · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00650862260182), received between Sep 24, 2020 and Sep 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

Device problems

  • Loose or Intermittent Connection1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 24, 2020Loose or Intermittent Connection; Mechanical Problem; Mechanical Problem

    N/A

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

    MAUDE report 10584235 ↗

Other INSTRUMENTS, SURGICAL, CARDIOVASCULAR devices

All INSTRUMENTS, SURGICAL, CARDIOVASCULAR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.