PowerPICC CK000171Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741042973), received between Nov 1, 2019 and May 21, 2021 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 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.

• MalfunctionMay 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC RN HAD A DIFFICULT TIME INSERTING THE PICC ON THIS PATIENT, WIRE WAS NOT THREADING WELL AND HAD TO USE TWO WIRES. PICC WAS SUCCESSFULLY PLACED AND WAS BEING INFUSED. AFTER APPROXIMATELY 24HRS OF BEING PLACED, IT WAS NOTICED THAT THE PICC WAS LEAKING ON THE EXTENSION LEG (THE RED/ NON POWER RATED SIDE). THERE WAS A HOLE IN THE PICC. THE PICC WAS THEN REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866922 ↗
• MalfunctionFeb 4, 2021Component Missing; Physical Resistance/Sticking

  IT WAS REPORTED "WHEN PICC WAS BEING INSERTED, THE WIRE WAS NOT GOING SMOOTHLY. RN WAS INSERTING, PULLING BACK, RE-INSERTING DUE TO RESISTANCE. FINALLY PULLED ENTIRE PICC OUT AND NOTICED THAT APPROX 1 INCH OF WIRE WAS MISSING. PATIENT RECEIVED MULTIPLE X-RAYS AND CT SCANS TO LOCATE WIRE. AS OF (B)(6), NO WIRE WAS LOCATED IN PATIENT. RN HAD THROWN AWAY THE PICC / WIRE ONCE IT WAS REMOVED FROM PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11282604 ↗
• DeathNov 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC WAS INSERTED ON 10/4 AND WORKED WELL. ON (B)(6) 2019, THE PATIENT EXPIRED. WHEN THE PICC WAS REMOVED, A HOLE WAS NOTICED IN THE MIDDLE OF THE PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 9269139 ↗