PowerPICC CK000870ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741184246), received between Aug 21, 2025 and Feb 19, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Product Quality Problem

  IT WAS REPORTED BY CUSTOMER THAT WHEN THEY WERE PLACING A PICC THE AMPULE FOR LIDOCAINE INJECTION SHATTERED WHEN THE NURSING WAS SNAPPING THE TOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389335 ↗
• MalfunctionSep 18, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED VIA MEDWATCH THAT WHILE PLACING PICC MICRO EZ MICRO INTRODUCER 4.5F FAILED TO BREAK AWAY AT ORANGE HUB. SHEATH DID NOT BREAK AT ALL. PICC PULLED BACK AND EXCHANGED OVER GUIDEWIRE SUCCESSFULLY. PROCEDURE COMPLETED WITHOUT DIFFICULTY USING 4.5 MICRO EZ MICRO INTRODUCER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085842 ↗
• MalfunctionAug 21, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE PICC WAS PLACED AS PER POLICY AND PROCEDURE AT BEDSIDE. UNABLE TO PEEL AWAY MICROEZ MICROINTRODUCER, 4.5F (1.6MM ID X 2.3 MM OD X 7CM LENGTH). MICROINTRODUCER DID NOT BREAK AT HUB AS IT IS SUPPOSED TO DO. INSTEAD, ONE OF THE ORANGE WINGS CRACKED OFF AND THE ORANGE PIECE CIRCLING THE TOP OF THE SHEATH STAYED INTACT MAKING IT IMPOSSIBLE TO PEEL AWAY THE SHEATH AND COMPLETE PICC INSERTION. PICC EXCHANGED OVER GUIDEWIRE WITHOUT DIFFICULTY, PROCEDURE COMPLETED. MAX BARRIER MAINTAINED THROUGHOUT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866309 ↗