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PowerPICC CK000335ARecalls & reported problems

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741101281), received between May 6, 2022 and May 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Mar 11, 2025Open, Classified

    Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

    Z-1507-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Fluid/Blood Leak1
  • Material Deformation1

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.

  • MalfunctionMay 6, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED "PICC LINE WAS LEAKING. UPON INVESTIGATION IT WAS LEAKING FROM THE END CAP. WHEN THEY TOOK THE END CAP OFF AND HOOKED UP THE FLUSH DIRECTLY TO THE PICC, IT DID NOT LEAK. NO ISSUES WITH ANY OTHER LINES."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14306788 ↗

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

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

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