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AccessPLUS™ 00884450007204Recalls & reported problems

Merit Medical Systems, Inc. · 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 00884450007204), received between Aug 18, 2020 and Aug 18, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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

  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionAug 18, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    THE ACCOUNT ALLEGES A PACKAGING DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A PROCEDURE. THE DEVICE WAS NOT USE. NO PATIENT CONTACT OR INJURY TO REPORT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10423557 ↗

Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices

All Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices →

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