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PowerPICC Provena CK000932Recalls & 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
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741188114), received between May 12, 2026 and Sep 10, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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: 0 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: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Contamination /Decontamination Problem1
  • Difficult or Delayed Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 10, 2026Contamination /Decontamination Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50713759 ↗
  • MalfunctionMay 12, 2026Difficult or Delayed Separation

    IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT WAS FOR A DILATOR FROM A 5 FR TRIPLE LUMEN PICC KIT. THE DILATOR WOULD NOT BREAK OFF ON 1 SIDE AND REMAINED LOOPED AROUND THE CATHETER AT THE WINGS. WE HAD TO CUT IT OFF WHICH WAS RISKY, BUT THE ALTERNATIVE WAS TO START OVER BUT THAT WAS OUR LAST TRIPLE KIT. THE TEAM PLACING THE PICC WAS ABLE TO TROUBLESHOOT AND INTERVENE TO PREVENT POTENTIAL HARM. THE INTERVENTION WAS THAT THE TEAM HAD TO USE STERILE SCISSORS TO RELEASE THE PLASTIC FROM AROUND THE SITE. THIS INTERVENTION COULD HAVE HAD POOR OUTCOMES, BUT THE TEAM MADE IT SUCCESSFUL. THE ONLY ALTERNATIVE WOULD HAVE BEEN TO PULL AND REPLACE THE LINE, BUT THE VEIN THAT WAS USED WAS THE ONLY OPTION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25150833 ↗

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

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

Sources and updates

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