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MYNX ACE Vascular Closure Device (6F/7F)

by Cordis US Corporation

PMA P040044

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

PMA P040044↗

FDA record

Trust

Unverified

Source FDA PMA, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP040044 Date17 Aug 2005ApprovedStatusActive

Official records

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0675-2024 FDA Class II initiated 28 Nov 2023
    • Ongoing Z-0674-2024 FDA Class II initiated 28 Nov 2023

    Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.

    • Terminated Z-2329-2016 FDA Class II initiated 13 Jul 2016

    A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.

Timeline

4 dated events

  1. Approved FDA PMA P040044
  2. Recall initiated FDA recalls Z-2329-2016
  3. Recall initiated FDA recalls Z-0675-2024
  4. Recall initiated FDA recalls Z-0674-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade name
Matrix Vascular Closure System (Vsg)
Generic name
Device, hemostasis, vascular
PMA number
FDA product code
MGB
Device class
Class III
Advisory committee
Cardiovascular
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MYNX ACE Vascular Closure Device (6F/7F) is a vascular hemostasis device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F, or 7F procedural sheath. It is part of the Matrix VSG System, Model MX-100, and is designed to achieve vascular closure following percutaneous arterial puncture.

Supplied as a sterile, single-use device, the MYNX ACE is intended for use in clinical settings such as catheterization labs and interventional radiology suites. It is not MRI conditional unless explicitly stated, and storage should follow manufacturer guidelines. The device holds FDA PMA approval (P040044) and is classified as a Class III device under product code MGB.

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