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PowerPICC Provena S9274108Recalls & reported problems

Bard Access Systems, Inc. · 4 Fr Dual Lumen · Class 2 · Implant

All models of PowerPICC Provena (116)

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 00801741130205), received between Dec 5, 2024 and Dec 5, 2024 — classified as 1 malfunction.

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

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Frayed1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionDec 5, 2024Material Frayed; Material Frayed

    IT WAS REPORTED THE END OF STYLET FELL OFF AND WAS LEFT INSIDE THE PATIENT. APPROXIMATELY 1.2CM OF THE WIRE BROKE OFF OF THE END. THE ENTIRE PIECE THAT BROKE OFF WAS RETAINED IN THE PATIENT, THE TEAM DECIDED TO NOT ATTEMPT RETRIEVAL OF THE WIRE. IMAGING WAS TAKEN. NO SIGNS OR SYMPTOMS REPORTED AS A RESULT OF RETAINED WIRE, BUT POTENTIAL FOR FUTURE NEGATIVE OUTCOME EXISTS IF THE WIRE BECOMES DISLODGED. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Foreign Body In Patient

    MAUDE report 20854728 ↗

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

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Sources and updates

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