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PowerPICC CK000413Recalls & reported problems

Bard Access Systems, Inc. · Catheter Placement Kit · Class 2 · Implant

All models of PowerPICC (118)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741096327), received between Jul 21, 2018 and Sep 17, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1
  • Fluid/Blood Leak1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED VIA MEDWATCH "FLUSHED LUMEN (GREY) OF PICC LINE, FLUSHING PRESSURE APPEARED TO HAVE A RUPTURED PICC LINE; VESSEL WAS INTACT". ADDITIONAL INFO RCVD 09/08/2020: UPON FLUSHING RUPTURED APPROXIMATELY 25CM BEYOND INSERT AT JCT OF BASILIC, BRACHIAL AND CEPHALIC VEINS IN SHOULDER NEAR SUBCLAVIAN VEIN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10548276 ↗
  • MalfunctionJul 21, 2018Break

    IT WAS REPORTED INSERTION OF CATHETER WAS STOPPED AS THE MAGNETIC WIRE BROKE DURING THE INSERTION. NO MIGRATION OF THE MAGNETIC WIRE AND NO HARM TO THE PATIENT WAS REPORTED. PLACEMENT OF A SECOND CATHETER WAS SUCCESSFUL.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7708500 ↗

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Sources and updates

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