PowerPICC SOLO CK000687Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741136535), received between Mar 21, 2019 and Sep 10, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE SECURLOC NEEDLE IN 4FR PICC KIT DID NOT SAFETY- NEEDLE EXPOSED. NO HARM RESULTED FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018902 ↗
• MalfunctionSep 9, 2025Activation Problem; Activation Problem

  IT WAS REPORTED, THE SECURLOC NEEDLE IN 4FR PICC KIT DID NOT SAFETY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000120 ↗
• MalfunctionAug 13, 2025Activation Problem; Activation Problem

  IT WAS REPORTED SECURLOC INTRODUCER NEEDLE FROM PICC KIT DID NOT SAFETY. GREEN SAFETY MECHANISM CAME OFF COMPLETELY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793711 ↗
• MalfunctionJul 10, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS FOUND ON THE CHLORAPREP STICK IN STERILE CUSTOM KIT. DEVICE WAS NOT USED ON PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8777742 ↗
• MalfunctionMar 21, 2019Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSERTION THE 3CG WIRE BENT IN A FEW PLACES AND DURING REMOVAL, THE WIRE COMPLETELY SEVERED. IT WAS STATED THE SAME PICC CATHETER WAS PLACED WITH A DIFFERENT WIRE. IT WAS STATED THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8441847 ↗