PowerMidline CK000856Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741159787), received between May 5, 2020 and Sep 8, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE MICRO INTRODUCER WOULDN'T GO INTO THE PATIENT'S ARM. THE GRAY SHEATH RIPPLED WHEN IT WAS TRIED TO ADVANCE THROUGH THE SKIN. NO PATIENT HARM REPORTED. ANOTHER KIT WAS NEEDED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17708912 ↗
• MalfunctionFeb 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "THE 16G PEEL AWAY SHEATH WITH DIALATOR IN THE MIDLINE KIT IS BARBED ON THE END, MAKING IT IMPOSSIBLE TO PLACE IN THE PATIENTS ARM AND CAUSING UNNECESSARY DISCOMFORT TO THE PATIENT. WE OPENED MST KIT AND USING THE DIALATOR IN THAT KIT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13507139 ↗
• MalfunctionAug 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED "THAT THERE ARE ISSUES WITH THE YELLOW/GRAY INTRODUCER IN CUSTOM MIDLINE CATHETER TRAY, CK000856. COMMENT IS THAT THE INTRODUCER IS TOO FLIMSY TO PROPERLY ADVANCE. IF SUFFICIENT FORCE IS APPLIED IN ATTEMPTING TO PUNCTURE THE SKIN OR VESSEL, THE GREY TIP OF OUTER PORTION OF INTRODUCER WILL BEGIN TO SPLIT AND SHRED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10376849 ↗
• MalfunctionMay 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED "THE REGULAR KITS WE GET FROM YOU ALL HAVE THE ORANGE WINGED INTRODUCERS IN THEM. THE "CUSTOM" KITS WE GET ALL HAVE THIS YELLOW WINGED ONE. THE OTHER ISSUE I WAS ADDRESSING IS THE AREA WHERE THE SHEATH AND THE CENTER PIECE MEET NEAR THE TIP. I'VE HAD A FEW OF THEM WHERE THERE WERE "PETALS" OF GRAY EXTENDING OVER THE GREEN PIECE. YOU CAN SEE THIS IN A COUPLE OF THE IMAGES I'VE ATTACHED.THESE PETALS, ONCE YOU PRESS THE GRAY PART INTO THE PATIENT'S SKIN, HAVE A TENDENCY TO FOLD BACK AND MAKE IT HARD TO ADVANCE THE INTRODUCER"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10027005 ↗