PowerPICC Provena CK000283ARecalls & 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 00801741141935), received between Jun 10, 2021 and Jun 10, 2021 — 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.
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.
MalfunctionJun 10, 2021Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED "I OPENED UP A REPLACEMENT INTRODUCER & IT SLID PERFECTLY IN, BUT DIDN¿T FULLY PEEL APART LEAVING A PLASTIC RING AGAIN AROUND THE CATHETER. COULDN¿T BREAK IT SO ENDED UP HAVING TO CUT IT LOOSE WITH THE SCALPEL (HIGH RISK FOR CATHETER PUNCTURE BUT HE CHECKED FUNCTION MULTIPLE TIMES AFTER PLACEMENT & DIDN¿T FIND ANY LEAKAGE)."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11974758 ↗
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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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