PowerPICC SOLO CK000587ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741135033), received between Mar 23, 2017 and Mar 29, 2018 — classified as 3 malfunctions.

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

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.

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.

• MalfunctionMar 29, 2018Folded; Torn Material

  IT WAS REPORTED THAT A DL POWER PICC SOLO LINE PLACEMENT WAS ATTEMPTED AN THE GUIDEWIRE WAS FOLDED OVER BACK UP INTO THE CATHETER AND TORN BETWEEN THE TWO LUMENS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7384008 ↗
• MalfunctionJun 8, 2017Break

  IT WAS REPORTED BY THE FACILITY THAT THE 3CG STYLET BROKE APART APPROXIMATELY 3-4 CM DISTAL OF THE TIP, FOLLOWING REMOVAL FROM THE CATHETER WITH MINOR HANDLING BY THE PHYSICIAN. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6625615 ↗
• MalfunctionMar 23, 2017Packaging Problem

  PER SALES REP, THE FACILITY REPORTED THAT WHEN THE PICC RN WENT TO GRAB THE KIT, IT WAS ALREADY OPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6428004 ↗