PowerPICC CK000670Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741130861), received between Jan 24, 2018 and Jul 13, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "I PLACED A PICC YESTERDAY AND WAS CALLED BACK TO FACILITY TODAY DUE TO NO BLOOD RETURN AND LEAKING. I NOTED THE PICC WAS LEAKING AT THE CONNECTION BETWEEN THE HUB AND THE EXTENSION TUBING. THE PICC WAS REMOVED." ADDITIONAL INFORMATION RECEIVED 06/30/2022: WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STATLOCK DATE OF OCCURRENCE: (B)(6) 2022 PLACEMENT DATE: (B)(6) 2022 EXPLANT DATE: (B)(6) 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15006036 ↗
• MalfunctionMar 12, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "DURING AN ECG PICC PROCEDURE I NOTICED THAT THE TRANSDUCER WIRE SIGNAL WAS LOST SUDDENLY. UPON REMOVAL I DISCOVERED THE TIP BROKEN IN TWO SPOTS. THE DISTAL TIP WAS BROKEN OFF BY HAND EASILY BUT I THOUGHT ID SAVE THE REST TO SEND BACK TO YOU" ADDITIONAL INFORMATION RECEIVED (B)(6) 2021: TRANSDUCER TIP BROKE SUDDENLY DURING INITIAL INSERTION IN TWO SPOTS. WHEN TRANSDUCER FEED WENT OUT TRANSDUCER WIRE WAS REMOVED AND EXAMINED. TIP INTACT BUT SEVERELY BROKEN. TIP EASILY REMOVED BY HAND AND THROWN OUT. SECOND PIECE NOT REMOVED. WAS THERE PATIENT HARM REPORTED?: NO. HAD TO REDO PROCEDURE DUE TO INABILITY TO NAVIGATE PICC WITH BROKEN TRANSDUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474902 ↗
• MalfunctionDec 11, 2020Break; Material Separation; Improper or Incorrect Procedure or Method; Break

  IT WAS REPORTED PATIENT KNOWN TO PULL LINES OUT, NURSE ENTERED ROOM AND LESS THAN 3 CMS OF PICC CATHETER WAS LEFT UNDER DRESSING. CATHETER WAS NOT IN PATIENTS ARM BUT UNDER THE DRESSING AND WHEN NURSE FLUSHED, SALINE "SHOT OUT OF THE TOP OF DRESSING." IT IS UNKNOWN WHERE REMAINDER OF CATHETER IS. PATIENT WAS SENT TO HOSPITAL AND ALL SCANS WERE INCONCLUSIVE. A NEW PICC WAS PLACED WITHOUT INCIDENT. ADDITIONAL INFORMATION RECEIVED 11/25/2020: PLACEMENT INFO: RIGHT BRACHIAL VEIN AT 37 CMS INTERNAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10993369 ↗
• MalfunctionJan 24, 2018Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED BY THE FACILITY VIA THE SALES REP THAT THEY HAD A 4FR DL PROVENA THAT LEAKED WHERE THE HUB MET THE TUBING. THEY STATED THAT THEY TRIED TO DO AN OVER THE WIRE EXCHANGE AND IT DIDN'T WORK, SO THEY HAD TO RE-ACCESS THE OTHER SIDE, WHICH UPSET THE PATIENT AS THERE WAS BRUISING AND SWELLING.

  Patient problems: Bruise/Contusion; Swelling

  MAUDE report 7217106 ↗