PowerPICC CK000897Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741184925), received between Jun 4, 2020 and Dec 2, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT SL PICC KITS SEEM TO BE VERY TIGHT IN PACKAGING AND DIFFICULT TO REMOVE/PLACE ON OUR STERILE FIELD FOR PROCEDURE. WE CAN EVEN CONTAMINATED A FEW TIMES TRYING TO REMOVE FROM PACKAGE, HAVING TO UTILIZE MORE SUPPLIES. THE OPENING OF THE PLASTIC PACKAGING IS NOT BIG ENOUGH TO SQUEEZE THE SUPPLIES OUT THROUGH. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700457 ↗
• MalfunctionMay 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "PATIENT'S PICC LINE WAS NOTED TO BE LEAKING AT THE JUNCTION WHERE THE CLEAR TUBING MEETS THE PLASTIC HUB JUST ABOVE THE CLAMP WHERE THE TUBING MEETS, THE HUB THAT READS "18G", PICC LINE CLAMPED TO SEE IF THERE WERE ANY PIN HOLES NOTED IN THE TUBING DURING FLUSHING AND NO FLUID MOVEMENT WAS NOTED IN THE CLEAR TUBING, HOWEVER FLUID FROM THE FLUSH CONTINUED TO LEAK OUT OF THE PICC LINE FROM THE SAME SPOT. PICC LINE WAS REMOVED AND NEW LINE PLACED. OTHER THAN A NEW LINE BEING PLACED, NO HARM TO PATIENT IDENTIFIED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881746 ↗
• MalfunctionSep 24, 2020Defective Component; Defective Component

  IT WAS REPORTED VIA MEDWATCH "WHILE RETRACTING THE PICC, RN NOTICED THAT THE MEASUREMENT MARKINGS WERE NOT VISIBLE. THEY APPEARED AT THE 13CM MARK AND WERE VERY CLEAR FROM 13CM TO THE TIP OF THE PICC. FROM 1CM TO 12CM THE MARKINGS ARE UNREADABLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10583812 ↗
• MalfunctionJul 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PICC WAS PLACED (B)(6) 2020. NURSE FIXED THE PICC WITH CYANOACRYLATE ADHESIVE AND DISINFECTED WITH ALCOHOLIC CHLORHEXIDINE. IT WAS STATED THE PATIENT SUFFERED A FALL AND HIT THE PICC. PATIENT CAME TO THE HOSPITAL AND DEVICE WAS FOUND TO BE LEAKING. ACCESS TEAM REMOVED PICC AND PLACED A NEW DEVICE. NO INJURIES TO PATIENT OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314525 ↗
• MalfunctionJun 4, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED VIA MS&S "PATIENT RECEIVED PICC CK000897 (LOT# REDX0252) LAST TUESDAY. SHE IS RECEIVING DAILY TREATMENT AND REPORTS HER PICC IS SLUGGISH." MS&S SPOKE WITH NURSE AT INFUSION CENTER WHO STATES THE PICC FLUSHED WITHOUT DIFFICULTY AND A BLOOD RETURN IS NOTED. "IT IS JUST A BIT SLOW". THE NURSE STATES THE FACILITY PROTOCOL IN PLACE USES TPA AND DYE STUDIES IF NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118563 ↗