PowerPICC SOLO CK000434Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741102875), received between Feb 2, 2016 and Feb 2, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2016Material Fragmentation; Unraveled Material; Physical Resistance

  FACILITY CONTACT REPORTED THAT A GUIDEWIRE MET RESISTANCE WHEN INSERTING. THE NEEDLE WAS REMOVED AND THE WIRE RESISTED REMOVAL. THE WIRE WAS TAKEN OUT AFTER INCREASED PRESSURE WAS APPLIED; HOWEVER, IT BEGAN TO UNRAVEL DURING REMOVAL. X-RAYS OBTAINED AFTER THE GUIDEWIRE WAS REMOVED NOTED A RESIDUAL FOREIGN BODY IN THE ARM ABOVE THE PLACEMENT SITE. THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED IN THE PATIENT'S RIGHT ARM. A NEW PICC LINE WAS SUCCESSFULLY PLACED IN THE LEFT ARM WITHOUT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5405795 ↗