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PowerPICC Provena CK000885Recalls & reported problems

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

All models of PowerPICC Provena (116)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741188824), received between Dec 1, 2021 and Dec 17, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (2 reports).

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 18, 2026.

Most reported problems

Device problems

  • Material Frayed2
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 17, 2021Material Deformation; Material Deformation

    IT WAS REPORTED "GUIDEWIRE FORMED INTO A KNOT DURING INSERTION." NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13025451 ↗
  • MalfunctionDec 1, 2021Material Frayed; Material Frayed

    IT WAS REPORTED "THE CUSTOMER STATES THEY HAVE HAD SEVERAL OCCURRENCES OF FRACTURED STYLETS." THE CUSTOMER DID NOT REPORT THE EXACT OCCURRENCE. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12911208 ↗
  • MalfunctionDec 1, 2021Material Frayed; Material Frayed

    IT WAS REPORTED THE CUSTOMER STATES THEY HAVE HAD A FRACTURED STYLET. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12911103 ↗

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

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Sources and updates

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