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MEDLINE ECVC7785Recalls & reported problems

Medline Industries, Inc. · VANTEX 8.5F 20CM 4L CVC BUNDLE · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653160349365), received between Feb 6, 2023 and Feb 6, 2023 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. May 15, 2023Open, Classified

    Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

    Z-2299-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

  • InjuryFeb 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE FACILITY "THE LINES ARE BRITTLE" AND THE LUMENS HAVE A "BUMP AROUND THE ORIFICE MAKING THEM ACCUMULATE FIBRIN AND REQUIRING ALTEPLASE AND REPEAT PROCEDURES".

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 16303342 ↗

Other Cardiac catheterization kit devices

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