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NA 26050Recalls & reported problems

Atrium Medical Corporation · VEIN GRAFT TUNNELING SYSTEM · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00650862260502), received between Jul 27, 2016 and Jul 27, 2016 — classified as 1 death.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Death1

Recent adverse event reports

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

  • DeathJul 27, 2016Insufficient Device Problem Information

    THE PHYSICIAN REPORTED HE WAS PERFORMING A FEMORAL-POPLITEAL BYPASS ON A PATIENT THAT RESULTED IN THE PATIENT HAVING EXCESSIVE BLEEDING FROM THE POPLITEAL VEIN. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. HE EXPIRED ON (B)(6) 2016 OF MULTI-ORGAN FAILURE.

    Patient problems: Death

    MAUDE report 5825292 ↗

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