PowerPICC Provena S1294108PDRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741134197), received between Nov 4, 2022 and Apr 16, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (4 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation4
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2024Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER THAT GUIDE WIRE CRIMPED WHEN REMOVED FROM PICC LINE TO TRIM THE LINE. ADDITIONAL INFORMATION PROVIDED 04/03/2024: IT WAS REPORTED THERE WAS NO SERIOUS INJURY OR HARM REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19119284 ↗MalfunctionFeb 14, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT "DR. HAS IDENTIFIED QUALITY ISSUES WITH OUR BARD POWERPICC PROVENA LINES. THERE IS NO SPECIFIC DIFFERENTIATION FOR WHAT PICCS WE ARE SEEING THE ISSUE WITH (SINGLE VS DUAL, 3-5FR) WIRE PULLS OUT SMOOTHLY, BUT THEN NOTED TO HAVE BE BENT TO THE POINT OF NEARLY BREAKING. RISK IS OF DISLODGMENT IN THE LINE/VESSEL" IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Insufficient Information
MAUDE report 16371605 ↗MalfunctionFeb 14, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT "DR. HAS IDENTIFIED QUALITY ISSUES WITH OUR BARD POWERPICC PROVENA LINES. THERE IS NO SPECIFIC DIFFERENTIATION FOR WHAT PICCS WE ARE SEEING THE ISSUE WITH (SINGLE VS DUAL, 3-5FR). WIRE PULLS OUT SMOOTHLY, BUT THEN NOTED TO HAVE BE BENT TO THE POINT OF NEARLY BREAKING. RISK IS OF DISLODGMENT IN THE LINE/VESSEL". IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: Insufficient Information
MAUDE report 16371604 ↗MalfunctionNov 4, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT "DR. HAS IDENTIFIED QUALITY ISSUES WITH OUR BARD POWERPICC PROVENA LINES. THERE IS NO SPECIFIC DIFFERENTIATION FOR WHAT PICCS WE ARE SEEING THE ISSUE WITH (SINGLE VS DUAL, 3-5FR), WIRE PULLS OUT SMOOTHLY, BUT THEN NOTED TO HAVE BE BENT TO THE POINT OF NEARLY BREAKING. RISK IS OF DISLODGMENT IN THE LINE/VESSEL".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15735429 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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