PowerPICC CK000417ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741100970), received between Aug 4, 2016 and Aug 4, 2016 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2016Break; Detachment of Device or Device Component

  ON 7/18/16 - FACILITY CONTACT REPORTED THAT A CATHETER "CAME APART" IN A PATIENT. ON 7/19/16 - ADDITIONAL INFORMATION RECEIVED FROM FACILITY CONTACT STATED THAT DURING THE PROCEDURE, THE HEALTHCARE PROFESSIONAL REPORTED THAT THE WIRE WOULD NOT THREAD. THEY ATTEMPTED TO REMOVE THE WIRE BUT MET RESISTANCE, AND THE TIP OF THE WIRE BROKE OFF IN THE PATIENT. UNDER FLUOROSCOPE IT WAS DETERMINED THAT THE WIRE WAS NOT IN THE VESSEL AND WAS IN THE TISSUE. PATIENT WILL REQUIRE AN ADDITIONAL SURGERY TO HAVE THE TIP OF THE WIRE REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5848566 ↗