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STEALTH® CLAMP INSERT A0C01Recalls & reported problems

Applied Medical Resources Corporation · CLAMP INSERT · 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 00607915113032), received between Jun 13, 2017 and Jun 13, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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

  • Migration or Expulsion of Device1

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.

  • MalfunctionJun 13, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

    PROCEDURE PERFORMED: NA. INCIDENT DESCRIPTION: "WE FINISHED OUR RECEIVING INSPECTION FOR INVOICE #93902737. SOME OF THE PRODUCTS DID NOT PASS THE RECEIVING INSPECTION BECAUSE OF PARTICULATE MATTER AND SO ON. PLEASE FIND THE ATTACHED REJECTED REPORT FOR THE DETAILED INFORMATION. WE WOULD LIKE APPLIED MEDICAL TO ISSUE CREDIT MEMO FOR THE REJECTED ITEMS, BUT WE DON'T NEED CREDIT MEMO ONLY FOR G6000 (LOT#1274065)." TYPE OF INTERVENTION: NA. PATIENT STATUS: NA.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6637356 ↗

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.