PowerPICC SOLO CK000900Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741184956), received between Jan 10, 2024 and Apr 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 11, 2025Class IOpen, 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 · Recall details · FDA record ↗

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.

• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT PATIENT CAME IN AS AN OUTPATIENT PICC APPOINTMENT WITH A PICC THAT HAD BEEN PLACED ONE MONTH PRIOR AND THE SOLO VALVE SEPARATED AND CUT OFF FROM THE LUMEN OF THE PICC. PATIENT NEEDED A NEW SL PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020000 ↗
• MalfunctionSep 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS MINIMAL BLEEDING FROM PICC. IT WAS REPORTED THE CATHETER FUNCTIONED AS INTENDED UNTIL THERE WAS A HOLE IN THE EXTENSION LEG OF THE PICC. PICC WAS INSERTED ON (B)(6) 2025 AND PRESENTED WITH THE HOLE ON (B)(6) 2025. IT IS UNKNOWN IF THE PATIENT WAS ON ANY BLOOD THINNERS. NO INTERVENTION WAS NEEDED FOR THE BLEEDING. PATIENT RECEIVED ANOTHER PICC AND THE BLEEDING RESOLVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22963695 ↗
• MalfunctionApr 3, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE SAFETY OF THE NEEDLE CAME OFF THAT WAS INCLUDED IN THE KIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769627 ↗
• MalfunctionJan 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT CATHETER WAS PLACED 12/1 AND ON 12/22, WE HAD TO REPLACE THE PICC, AND THE OLD PICC APPEARS TO HAVE A HOLE IN THE LINE AT APPROXIMATELY THE 10CM MARK. IT WAS CUT AT 52 CM WITH 5CM OUTSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18485357 ↗