PowerMidline CK000799ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741188084), received between Apr 1, 2020 and Jun 20, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED, HAD AN ISSUE WHEN PLACING A MIDLINE AND THE DILATOR NOT PEELING AWAY CORRECTLY. ADDITIONAL INFORMATION PROVIDED 09-JUNE-2025: THE CATHETER WAS STILL ATTACHED BY A THIN RING OF PLASTIC ON ONE SIDE OF THE DILATOR. IT TOOK A LOT OF PRESSURE TO BREAK THIS PLASTIC CIRCLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301629 ↗
• MalfunctionApr 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER THE NEEDLE HAS BLACK SPECS INSIDE THE HUB. THIS NEEDLE WAS OPENED BEFORE THE SPECS WERE DISCOVERED BUT WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940323 ↗
• MalfunctionApr 30, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER WHEN SLIDING THE SAFETY INTO PLACE ON THE NEEDLE, THE SAFETY SLIDES ALL THE WAY OFF THE NEEDLE AND DETACHES FROM THE NEEDLE. THE NEEDLE REMAINS OPEN AND UNSAFE. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT OR HEALTHCARE PROFESSIONAL. IT WAS REPORTED THIS OCCURRED WITH NINE DEVICES. THIS REPORT ADDRESSES ALL NINE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938740 ↗
• MalfunctionApr 30, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER WHEN SLIDING THE SAFETY INTO PLACE ON THE NEEDLE, THE SAFETY SLIDES ALL THE WAY OFF THE NEEDLE AND DETACHES FROM THE NEEDLE. THE NEEDLE REMAINS OPEN AND UNSAFE. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT OR HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938707 ↗
• MalfunctionMay 21, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED "DURING THE PEELING THE ORANGE HANDLE FRACTURED OFF THE GREY SHEATH HALFWAY THROUGH THE PEELING PROCESS. THE PROCEDURALIST HAD TO PULL THE MIDLINE AND SHEATH BACK TO CONTINUE TO REMOVE THE SHEATH FROM AROUND THE MIDLINE WITH HER FINGERS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465607 ↗
• MalfunctionMay 24, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE PEEL AWAY SHEATH OF A MIDLINE CATHETER MET RESISTANCE AT THE VERY END AS THOUGH IT WAS NOT PERFORATED RESULTING IN THE INABILITY TO FULLY PEEL IT AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872897 ↗
• MalfunctionApr 1, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "THERE WERE WHAT APPEARS TO BE "CARDBOARD" SHAVINGS IN THE SEALED KIT". THE KIT WAS NOT USED ON A PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913827 ↗