PowerPICC CK000775Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741142604), received between Dec 7, 2018 and Feb 20, 2020 — classified as 5 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS A HAIR IN THE PICC KIT WHEN OPENED. THE KIT WAS NOT USED ON THE PATIENT. 2/3/2020- ADDITIONAL INFORMATION RECEIVED STATED, " LONG HAIR WAS WOVEN AROUND THE CATHETER IN THE TRAY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732316 ↗
• MalfunctionFeb 12, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THERE WAS RESISTANCE THREADING IT AROUND THE AXILLARY AND SUBCLAVIAN AREA AND THE WIRE SEEMED LIKE IT WAS FLIPPING. THE EMPLOYEE TOOK OUT THE WIRE COMPLETELY FROM THE CATHETER AND NOTICED IT WAS NOT FULLY INTACT. A NEW KIT WAS OPENED AND THE WIRE WAS INSERTED THROUGH THE CATHETER WITH NO ISSUES. 1/28/2019-ADDITIONAL INFORMATION RECEIVED STATED, "DIFFICULTY THREADING THE PICC AND NOTICED WIRE WAS NOT FULLY INTACT. REPLACED WITH NEW STERILE PICC AND IT THREADING OKAY PER PROCEDURE NOTES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700902 ↗
• MalfunctionFeb 12, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PICC WAS PRIMED WITH NS AND THE EMPLOYEE COMPLETELY REMOVED THE WIRE FROM THE PICC BEFORE TRIMMING. THEN SHE NOTICED IT WAS DIFFICULT TO THREAD THROUGH AND WHEN SHE SAW THE END OF THE WIRE SHE NOTICED A LITTLE PIECE HAD FALLEN OFF THE END OF THE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700811 ↗
• MalfunctionFeb 12, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE WIRE WAS FRAYED/BROKEN AND A NEW KIT HAD TO BE OPENED TO COMPLETE THE PROCEDURE. IT WAS STATED THERE IS AN AREA AROUND THE 30CM MARKER THAT APPEARS TO BE KINKED. 01/23/2020- ADDITIONAL INFORMATION FROM FACILITY STATED, "WHILE INSERTING THE PICC ABOUT 25CM, RESISTANCE WAS FELT. AT THIS TIME THE CATHETER WAS REMOVED AND THE INSERTER NOTICED SLIGHT TENSION WITH THE REMOVAL. UPON INSPECTING THE PICC, THE INSERTER NOTICED A SIGNIFICANT BEND IN THE CATHETER APPROXIMATELY AT THE 30CM MARK. THE INSERTED THEN REMOVED THE STYLET AND WIRE COMPLETELY FOR INSPECTION. THE INSERTER NOTICED THE WIRE WAS BARELY INTACT. A NEW KIT WAS UTILIZED AND THE INSERTION WAS COMPLETED WITHOUT DIFFICULTY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700343 ↗
• MalfunctionDec 7, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ORANGE TAB BROKE OFF THE INTRODUCER SHEATH WHILE IT WAS BEING PEELED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8143077 ↗