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STEALTH® CLAMP INSERTS A0A03Recalls & reported problems

Applied Medical Resources Corporation · Clamp Inserts · 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 00607915112998), received between Mar 6, 2017 and Mar 6, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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

  • Detachment Of Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMar 6, 2017Detachment Of Device Component; Detachment Of Device Component

    CAROTID ARTERY- "DURING THE COUNT AT THE END OF THE PROCEDURE, STAFF NOTICED THE BLUE PAD HAD COME OFF OF THE PLASTIC FRAME/INSERT AND THE PADS WERE LOCATED INSIDE THE PATIENT. THEY DID NOT KNOW THE LOT # SO THEY GAVE ME ALL 3 THEY HAD ON THE SHELF. LOT # 1191520, 1176337, 1182598." PATIENT STATUS: UNKNOWN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6382265 ↗

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.