PowerPICC CK0000101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741036255), received between Feb 3, 2016 and Feb 15, 2017 — classified as 1 injury, 2 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 16, 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.

• MalfunctionFeb 15, 2017Device Contamination With Biological Material

  PER SALES REPRESENTATIVE, FACILITY REPORTED THAT PRIOR TO PLACEMENT, THE HEALTHCARE PROFESSIONAL NOTICED A HAIR IN THE STERILE FIELD AROUND THE PROBE COVER.

  Patient problems: No Patient Involvement

  MAUDE report 6332856 ↗
• MalfunctionFeb 15, 2017Break

  PER SALES REPRESENTATIVE, FACILITY REPORTED THAT THE HEALTHCARE PROFESSIONAL GAINED ACCESS TO THE PATIENT, PLACED THE WIRE AND PROCEEDED TO PLACE THE INTRODUCER/SHEATH. WHEN REMOVING THE SHEATH, THE INTRODUCER WAS IN TWO PIECES. THE WAND OF THE INTRODUCER WAS SEPARATED FROM THE HUB. NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6332762 ↗
• InjuryFeb 3, 2016Insufficient Device Problem Information

  ON 1/14/2016 - THE SALES REPRESENTATIVE REPORTED THE FOLLOWING INFORMATION FROM HIS CUSTOMER: IT WAS DECIDED TO ABORT A PICC INSERTION BECAUSE THE PATIENT'S CLAUSTROPHOBIA WAS CAUSING HIM TO BE AGITATED. LATER, WHEN THE PATIENT WAS SEDATED, THEY PLACED THE PICC LINE. THE FACILITY REPORTED THAT THEY KNEW THE PICC INSERTION WAS SUCCESSFUL BECAUSE OF THE MAGNETIC TRACKING THAT WAS PRESENT DURING IT'S PLACEMENT. THEY REPORTED THAT A FEW DAYS FOLLOWING THE PICC LINE INSERTION, A CATHETER WAS BEING PLACED, AND IT WAS NOTED THAT A 3CM FOREIGN BODY WAS IN THE PATIENT'S HEART. IT WAS REPORTED TO FA THAT THIS WAS "DEFINITELY THE STYLET", BELIEVED TO BE THERE FROM THE PREVIOUS PICC LINE PLACEMENT. A RETRIEVAL WAS ATTEMPTED, BUT IT WAS UNSUCCESSFUL. THE METHOD OF RETRIEVAL IS UNKNOWN. FOLLOWING THE EVENT, THE STAFF AT THE FACILITY "PLAYED" WITH THE STYLET TO SEE IF IT EASILY FELL OFF.

  Patient problems: No Code Available

  MAUDE report 5408430 ↗