PowerPICC SV Catheter 1274108Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741086908), received between Oct 20, 2017 and Feb 15, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICCS ARE LEAKING. HAD TO CLEAN UP MESS AND REPLACE. NO OTHER INFORMATION WAS PROVIDED. 1/31/2024: THREE DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710913 ↗
• MalfunctionFeb 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICCS ARE LEAKING. HAD TO CLEAN UP MESS AND REPLACE. NO OTHER INFORMATION WAS PROVIDED. 1/31/2024 - THREE DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710810 ↗
• MalfunctionAug 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICCS ARE LEAKING. HAD TO CLEAN UP MESS AND REPLACE. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NO PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494668 ↗
• MalfunctionAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CUSTOMER RETURNED A LEAKING 3FR PICC. HAD TO CLEAN UP MESS AND REPLACE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482437 ↗
• MalfunctionMay 30, 2018Break; Kinked

  DURING SAMPLE EVALUATION A DAMAGED GUIDE WIRE WAS FOUND RETURNED WITH CATHETER. UPON INQUIRY IT WAS REPORTED VIA SALES REP THAT THE GUIDE WIRE WAS DAMAGED DURING INSERTION, AND THAT NO PATIENT COMPLICATIONS RESULTED FROM USE. FROM THE INVESTIGATING ENGINEER: THERE WAS A BREAK IN THE POLYIMIDE TUBING OF THE 3CG STYLET. THE STYLET SHOWED EVIDENCE OF USE. THE POLYIMIDE TUBING SHOWS KINKS BETWEEN MAGNETS AT THE PROXIMAL END. THE DISTAL END OF THE POLYIMIDE TUBING IS STRAIGHT AND NOT KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555245 ↗
• MalfunctionMay 15, 2018Detachment Of Device Component; Connection Problem

  IT WAS REPORTED THAT THE CATHETER WAS REMOVED DUE TO BREAK/SEPARATION WHERE RED HUB CONNECTS TO THE EXTENSION LEG. NO INJURY WAS REPORTED AND A NEW LINE WAS PLACED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7516921 ↗
• MalfunctionOct 20, 2017Leak/Splash

  FACILITY CONTACTED THE SALES REP WHEREBY THEY ASKED IF THEY COULD RUN A WIRE THROUGH EITHER PORT, OF THE SV PICC LINE FOR EXCHANGE. THE SV PICC BEGAN TO LEAK OUT ON THE PROXIMAL HUB PAST THE CLAMP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6965129 ↗