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STEALTH® CLAMP INSERTS A0A11Recalls & 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 00607915112967), received between Mar 15, 2017 and Mar 15, 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 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.

  • MalfunctionMar 15, 2017Detachment Of Device Component; Detachment Of Device Component

    PROCEDURE PERFORMED: UNKNOWN - "(ON (B)(6) 2017: DURING PROCEDURE) A MEDICAL STAFF USED THE INSERT TO OCCLUDE A VESSEL. THE VESSEL OCCLUSION WAS COMPLETED SUCCESSFULLY. THEN THE MEDICAL STAFF TRIED TO REMOVE THE INSERT FROM THE VESSEL, THE MEDICAL STAFF FOUND THAT THE RUBBER SEPARATED FROM THE BASE. PLEASE SEE THE ATTACHED PICTURE BELOW. THIS EVENT DIDN'T AFFECT THE PATIENT." TYPE OF INTERVENTION: NA. PATIENT STATUS: NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6408120 ↗

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.