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Stealth® Clamps A3219Recalls & 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 00607915114244), received between Apr 9, 2021 and Apr 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 9, 2021Fracture; Fracture

    PROCEDURE PERFORMED: CAGS. [NAME] WAS SCRUBBED FOR THE CASE ONE OF THE CLAMPS THAT HAS THE INSERTS THAT THEY PUT ON THE JAWS. [NAME] APPLIED THE INSERTS TO THE JAWS AND DID ONE CLICK OF THE RATCHET AS SHE NORMALLY DOES AND PUT IT ON HER MAYO. WHEN SHE WENT TO GIVE IT TO THE SURGICAL TEAM THEY NOTICED THAT THE RATCHET WASN¿T WORKING. THEY LOOKED AT THE BOX JOINT OF THE CLAMP AND NOTICED A FRACTURE THROUGH ONE OF THE ARMS. THIS SAME ISSUE HAS HAPPENED IN JANUARY WITH ANOTHER 1 OF 6 CLAMPS THAT WERE PURCHASED AT THE SAME TIME. INTERVENTION: NI. PATIENT STATUS: PATIENT IS FINE, AND COMPLETELY UNAFFECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11642445 ↗

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.