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
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 ↗
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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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