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PowerPICC SOLO CK000505ARecalls & reported problems

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

All models of PowerPICC SOLO (78)

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

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 00801741119095), received between Apr 17, 2019 and Apr 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 18, 2026.

Most reported problems

Device problems

  • Difficult to Insert1

Patient problems

  • Discomfort1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 17, 2019Difficult to Insert

    IT WAS REPORTED THAT DURING PICC PLACEMENT, INTRODUCER WAS PLACED OVER WIRE BUT UNABLE TO BE INSERTED. PATIENT EXPERIENCED DISCOMFORT, RN WITHDREW PEEL AWAY SHEATH AND OBSERVED A BLUNT TEAR/NOTCH AT THE DISTAL END OF THE PEEL AWAY SHEATH, THE DILATOR DID NOT APPEAR TO BE AFFECTED. NO PATIENT HARM OBSERVED OTHER THAN DISCOMFORT. RN OPENED A NEW INTRODUCER AND PICC WAS PLACED SUCCESSFULLY.

    Patient problems: Discomfort

    MAUDE report 8525125 ↗

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Sources and updates

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