PowerPICC Provena S1385108D6Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741232237), received between Oct 22, 2025 and Mar 2, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (2 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Material Frayed

  IT WAS REPORTED A FEW KITS IN THE LOT HAD A PIECE OF THE WIRE BREAK OFF INSIDE OF PATIENTS. NO FURTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24490048 ↗
• MalfunctionOct 23, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT WHILE PLACING A PICC ON A VERY ILL CANCER PATIENT. WHILE ACCESSING PATIENT FOR PICC LINE, GOT INTO VEIN WITH GREEN ACCESS NEEDLE, THREAD GUIDEWIRE AND REMOVED ACCESS NEEDLE OVER THE WIRE, ATTEMPTED TO SAFETY GREEN ACCESS NEEDLE AND THE GREEN SAFETY FLEW OFF LEAVING US UNABLE TO SAFETY THE NEEDLE NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368896 ↗
• InjuryOct 22, 2025Material Frayed; Material Frayed

  IT WAS REPORTED A SMALL TIP OF THE GUIDEWIRE WAS LEFT IN THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23359975 ↗