PowerPICC SOLO CK000501ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741140815), received between Jul 31, 2019 and Apr 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "CT SCAN WAS PERFORMED WITH HIGH-PRESSURE INJECTION. THE CT TECH RECOGNIZED THAT THE IMAGE WAS LACKING CONTRAST RESOLUTION AND CHECK THE PATIENT'S ARM AND NOTICED LARGE AMOUNT OF SWELLING ABOVE THE INSERTION SITE. WE WERE CALLED TO REPLACE THE LINE, I REQUESTED THE NURSE SAVE THE CATHETER AND NOT PERFORM A GUIDEWIRE EXCHANGE. THE PATIENT NEEDED A CT SCAN. MY RECOMMENDATION WAS TO REPLACE THE LINE IN THE OTHER ARM WITH A DIFFERENT LOT NUMBER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Extravasation; Swelling/ Edema

  MAUDE report 21929145 ↗
• MalfunctionJan 14, 2021Break; Difficult to Advance

  IT WAS REPORTED "THE 3CG STYLET BROKE OFF THE PICC. RN STATED HE HAD TROUBLE ADVANCING THE PICC AND DECIDED TO RETRACT IT, HE THEN DISCOVERED THE 3CG STYLET HAD BROKEN OFF." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11170423 ↗
• MalfunctionJul 31, 2019Obstruction of Flow

  IT WAS REPORTED VIA MS&S "NURSE STATES HAS A PATIENT WITH A POWERPICC THAT WILL NOT FLUSH. MS&S DISCUSSED POSSIBLE CAUSES OF OCCLUSION. RECOMMENDED SHE SPEAK WITH THE MD ABOUT THE USE OF CATHFLO OR A DYE STUDY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8848987 ↗