PowerPICC CK000411Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741096303), received between Mar 7, 2016 and May 24, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Kinked” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 11, 2025Open, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · FDA record ↗

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.

• MalfunctionMay 24, 2018Bent; Break

  IT WAS REPORTED THAT THE WIRE WAS BENT AT THE END AND NEEDED TO BE REMOVED FROM PATIENT. NO OTHER INFORMATION WAS PROVIDED. ON 5/2/2018 - RETURNED WIRE IS BENT AND BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7541046 ↗
• MalfunctionMar 7, 2016Kinked; Migration or Expulsion of Device

  PER SALES REPRESENTATIVE, A NURSE REPORTED THAT WHEN PLACING TWO PICCS, THE WIRE MIGRATED BACKWARDS AFTER THE WIRE WAS "BENT OVER THE END AND TIGHTENED DOWN". NURSE STATED THAT SHE THOUGHT THE WIRE KNOTTED BECAUSE ONLY 4 CM WAS LEFT INSIDE THE PATIENT. AT ONE POINT, THE NURSE REPORTED THAT SHE WAS ABLE TO REMOVE THE WIRE WHICH CAME OUT KINKED AND THEN RE-INSERTED IT UP TO THE INITIAL BEND MADE WHEN STARTED. (B)(6) 2016 - PER EMAIL RECEIVED FROM NURSE ON (B)(6) 2016: RN REPORTS THAT FROM THE BEGINNING, THE PATIENT TOLD HIM THAT A PAST PICC WAS A DIFFICULTY. THE PATIENT SAID IT COILED UP IN HIS CHEST. RN STATES THERE WAS NO HARM TO PATIENT. A NEW PICC WAS PLACED BY THEIR TEAM AT "SPECIALS" UNDER FLUOROSCOPY. RN ALSO REPORTED THAT GETTING THE CATHETER TO DROP INTO THE SVC WAS A MAJOR PROBLEM. THEY MOVED THE ARM SEVERAL TIMES AND LOWERED AND RAISED THE PATIENT'S HEAD AND HEAD OF BED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5485065 ↗
• MalfunctionMar 7, 2016Kinked; Migration or Expulsion of Device

  PER SALES REPRESENTATIVE, A NURSE REPORTED THAT WHEN PLACING TWO PICCS, THE WIRE MIGRATED BACKWARDS AFTER THE WIRE WAS "BENT OVER THE END AND TIGHTENED DOWN." NURSE STATED THAT SHE THOUGHT THE WIRE KNOTTED BECAUSE ONLY 4 CM WAS LEFT INSIDE THE PATIENT. AT ONE POINT, THE NURSE REPORTED THAT SHE WAS ABLE TO REMOVE THE WIRE WHICH CAME OUT KINKED AND THEN RE-INSERTED IT UP TO THE INITIAL BEND MADE WHEN STARTED. (B)(6) 2016 - PER EMAIL RECEIVED FROM NURSE ON (B)(6) 2016: RN REPORTS THAT FROM THE BEGINNING, THE PATIENT TOLD HIM THAT A PAST PICC WAS A DIFFICULTY. THE PATIENT SAID IT COILED UP IN HIS CHEST. RN STATES THERE WAS NO HARM TO PATIENT. A NEW PICC WAS PLACED BY THEIR TEAM AT "SPECIALS" UNDER FLUOROSCOPY. RN ALSO REPORTED THAT GETTING THE CATHETER TO DROP INTO THE SVC WAS A MAJOR PROBLEM. THEY MOVED THE ARM SEVERAL TIMES AND LOWERED AND RAISED THE PATIENT'S HEAD AND HEAD OF BED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5485064 ↗