PowerPICC Provena CK000904ARecalls & 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
- 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 00801741222979), received between Mar 21, 2024 and Mar 21, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (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
- Difficult or Delayed Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT THEY WERE PLACING THE PICC AND GRASPED THE ORANGE HANDLES OF THE PEEL AWAY SHEATH TO REMOVE IT BUT IT WOULDN'T FULLY TEAR APART. A THIN PIECE OF THE ORANGE HANDLES WOULD NOT TEAR. THEY COULDN'T KEEP PULLING ON THE HANDLES BECAUSE IT WAS PUTTING PRESSURE ON THE CATHETER. I HAD TO CAREFULLY USE THE SCALPEL TO GET THE PIECE TO COMPLETELY COME APART. THE PICC WAS NOT DAMAGED. EVERYTHING ELSE IN THE PROCEDURE WAS APPROPRIATE. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18949962 ↗
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- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
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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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