PowerPICC 1174108D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741154737), received between Nov 6, 2019 and Oct 22, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 11, 2025Open, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · FDA record ↗

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.

• MalfunctionOct 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THEY HAD STRANGE BREAK IN A PICC LINE THAT OCCURRED INSIDE A PATIENT'S ARM. THE LINE AT INSERTION WAS AT 0 AND THE BREAK IN THE LINE WAS AT 2. WHEN HE PRESENTED BACK FROM HOME, THE LINE WAS STILL AT 0, BUT IT DID OCCUR AT HOME SO WE CANNOT ACCOUNT FOR THE LINE THE ENTIRE TIME. THE LINE NEEDED TO BE REMOVED AND REPLACED DUE TO LEAKING INTO PATIENT'S ARM. PATIENT EXPERIENCED PAIN WHEN INFUSING OR LINE WAS FLUSHED. LINE HAS TWO SMALL SLITS, PARTIAL BREAK, WHERE LINE WAS BENT IN ARM. THE CATHETER WAS SUCCESSFULLY REMOVED. NO OTHER INTERVENTION WAS NECESSARY. THE LINE WAS DRESSED AND COVERED WITH A TEGADERM OVER THE INSERTION SITE. THE PATIENT CAME INTO THE ER WITH PAIN ON FLUSHING AND INFUSION BECAUSE OF INABILITY TO TOLERATE USING THE LINE. HE MISSED A DOSE OF ANTIBIOTICS AS A RESULT.

  Patient problems: Pain

  MAUDE report 23359976 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD A POWERPICC THAT HAD A BREAK IN THE LINE NEAR THE HUB. THE PATIENT'S LINE NEEDED TO BE REPLACED. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903854 ↗
• MalfunctionFeb 24, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE GREEN SAFETY MECHANISM BECOME UNATTACHED DURING SAFETY DEPLOYMENT. NO OTHER INFORMATION WAS PROVIDED AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453070 ↗
• MalfunctionSep 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC WAS PLACED ON AN EXTREMELY LARGE PATIENT BACK ON (B)(6). IT WAS DISCONTINUED AND AROUND THE 8CM MARK THE PICC WAS FRACTURED. I SUSPECT THE LINE WAS KINKED IN THE ARM DUE TO PATIENT'S HABITUS. IT IS POSSIBLE THAT A CLINICIAN ATTEMPTED TO RESTORE PATENCY WITH AN INAPPROPRIATELY SIZED SYRINGE IF/WHEN RESISTANCE WAS MET. THE LINE WAS REMOVED PRIOR TO COMPLETION OF THERAPY AND A SHORT PIVC WAS PLACED TO FACILITATE THE LAST DOSE OF ABX. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287916 ↗
• MalfunctionApr 22, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "LEAKING AT THE HUB." ADDITIONAL INFORMATION RECEIVED 03/31/2022 "THERE WASN T A CRACK IN THE HUB THAT WAS CAUSING A LEAK. IT WAS A MISALIGNMENT OF THE TWO HALVES OF THE HUB THAT CAUSED THE NEEDLELESS CONNECTOR TO NOT SIT CORRECTLY. NO MATTER HOW TIGHT YOU TRIED TO PUT THE CAP ON, THE DEVICE LEAKED WHEN IT WAS FLUSHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190392 ↗
• MalfunctionFeb 16, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED "UPON PEELING SHEATH, INNER LUMEN DID NOT COMPLETELY PEEL AND UNABLE TO RELEASE CATHETER" NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544352 ↗
• MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC WAS FOUND CONSISTENTLY LEAKING INFUSATE AT SITE, NOTED FROM DAY ONE AND HOME HEALTH NURSES HAD TO DO PRN DRESSING CHANGES ALL THE TIME. CXR WAS DONE AND IT WAS POSITIONED IN LOWER SVC. THE LINE WAS PULLED AND A NEW LINE PLACED IN THE OPPOSITE ARM. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285487 ↗