Skip to content

PowerFlow AIV14Recalls & reported problems

Bard Access Systems, Inc. · PowerFlow IV Port Access System, 14G · 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 00801741136634), received between Mar 26, 2021 and Mar 26, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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

  • Device Markings/Labelling Problem1

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.

  • MalfunctionMar 26, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT PRIOR TO PORT PLACEMENT, THE PRODUCT PACKAGING OF PORT ALLEGEDLY HAD A LABELLING ISSUE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11573939 ↗

Other Subcutaneous implanted apheresis port devices

All Subcutaneous implanted apheresis port devices →

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