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PowerPICC CK000854Recalls & 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 00801741155741), received between May 31, 2019 and Feb 5, 2020 — classified as 2 malfunctions.

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

Most reported problems

Device problems

  • Flushing Problem1
  • Fracture1
  • Leak/Splash1
  • Material Deformation1

Patient problems

  • No Consequences Or Impact To Patient1
  • Pain1

Recent adverse event reports

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

  • MalfunctionFeb 5, 2020Material Deformation; Material Deformation

    IT WAS REPORTED "ON (B)(6) 2020 WE HAD A FAULTY INTRODUCER IN A 4FR SL PICC KIT (LOT#REDT4612). THE INTRODUCER HAD A BURR ON THE END AND A STRIATED CIRCULAR LINE IN THE MIDDLE OF THE CATHETER."

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9672118 ↗
  • MalfunctionMay 31, 2019Flushing Problem; Fracture; Leak/Splash

    IT WAS REPORTED "SINGLE LUMEN PICC WITH CUT TO EXTERNAL TUBING IN CLAMP AREA. PT STATES HOME HEALTH NURSE DID WEEKLY DRESSING CHANGE ON PICC SITE AND IMMEDIATELY AFTER PICC FLUSHED THE EXTERNAL TUBING HAD A LEAK. PT WENT TO ED WITH COMPLAINT OF PAINFUL BLOOD/FLUIDS LEAKING FROM PICC LINE AND UNABLE TO FLUSH LINE. CONCERN ABOUT POSSIBLE FRACTURE OF PICC LINE. PATIENT TAKEN TO SURGERY FOR REPLACEMENT OF PICC LINE".

    Patient problems: Pain

    MAUDE report 8659018 ↗

Other Catheter, intravascular, therapeutic, long-term greater than 30 days devices

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Sources and updates

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