PowerPICC SOLO CK000544ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741121593), received between Oct 4, 2016 and Oct 4, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionOct 4, 2016Bent; Break; Component Falling; Retraction Problem; Physical Resistance

  PER SALES REP, FACILITY REPORTED THAT THE PICC WAS DIFFICULT TO PLACE AND WAS GOING UP THE IJ. IT WAS STATED THAT THE NURSE WITHDREW THE CATHETER AND NOTICED THE WIRE WAS BENT AND IT FELL OFF IN HER HAND. THEY REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE FACILITY REPORTED THE GUIDEWIRE COMPLETELY BROKE AS THE NURSE RETRACTED IT FROM THE CATHETER. THE NURSE STATED, "I HAD MET SOME RESISTANCE ADVANCING THE CATHETER WITH THE GUIDEWIRE IN. I RETRACTED THE CATHETER AND ATTEMPTED TO RE- ADVANCE IT WHILE FLUSHING IT. STILL MET WITH RESISTANCE SO I REMOVED THE GUIDE WIRE. IT IS THEN I OBSERVED THE WIRE WITH A BEND AND WHEN I TOUCHED IT, IT BROKE OFF. I READVANCED THE CATHETER WHILE FLUSHING AND WITHOUT SHERLOCK CONFIRMATION OF THE TIP LOCATION. IT WAS IN THE SVC BUT I OBSERVED THAT THE PATH TAKEN WAS A SHARP 90 DEGREE DROP SO I THINK THE CATHETER WAS HITTING AT THE 90 TURN AND TRIED FLIPPING BACKWARDS WHICH WEAKENED THE WIRE."

  Patient problems: No Information

  MAUDE report 5998429 ↗