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Malleable Occlusion Device A3400Recalls & reported problems

Applied Medical Resources Corporation · Vascular Clamp, Reusable · Class 2

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 00607915110802), received between Jan 10, 2017 and Jan 10, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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

  • Unintended Movement1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJan 10, 2017Unintended Movement; Unintended Movement

    CAGS- "USED THE CLAMP TO CLAMP AORTA. CLAMP KEPT COMING LOOSE AND CAUSING AORTA TO LEAK, CHANGED TO A REUSABLE PRODUCT TO CLAMP AORTA IN PREFERENCE TO THIS PRODUCT. SURGEON BELIEVES THE HANDLE IS FAULTY AND NOT SECURING PROPERLY. DIDNT WANT TO TRY A NEW HANDLE AT THE TIME AS DIDNT TRUST THE CLAMP BUT WANTS THE HANDLE CHECKED FOR FAULT." PATIENT STATUS- NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6239300 ↗

Other Clamp, Vascular devices

All Clamp, Vascular devices →

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