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N/A (REF G408321)Recalls & reported problems

Innovative Health LLC · Agilis NxT Steerable Introducer, 71 cm · 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 10841898128196), received between Oct 18, 2022 and Oct 18, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1

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.

  • MalfunctionOct 18, 2022Material Separation; Material Separation

    THIS DEVICE WAS REPORTED TO NOT WORK PROPERLY. UPON INSPECTION, THE DEVICE WAS FOUND TO HAVE A DETACHED SIDE-PORT. IT IS UNKNOWN WHEN THE ISSUE WAS IDENTIFIED. NO PATIENT INJURIES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15629434 ↗

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