PowerPICC CK000677Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741131790), received between Aug 3, 2023 and Dec 31, 2024 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2024Break; Break

  IT WAS REPORTED THAT PICC FRACTURED AT 5CM DURING REMOVAL. EXTENDED STAY IN ER. PT ARRIVED FOR A "SIMPLE" PICC LINE REMOVAL. ENDED UP WITH 38CM OF RETAINED CATHETER WHICH PER CXR WAS INTACT. PATIENT UNDERWENT FLURO/IR PROCEDURE TO REMOVE THE REMAINING CATHETER VIA ACCESS OF THE FEMORAL VEIN. PATIENT TOLERATED WELL AND WAS DISCHARGED TO HOME WITH HIS SPOUSE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21047771 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE DEVICE WAS LEAKING. THERE WAS A SMALL OPENING IN THE PICC LINE WHEN REMOVED. INFILTRATED INTO ARM, REQUIRED TREATMENT AS WELL AS CAUSING A DELAY IN CARE.

  Patient problems: Extravasation

  MAUDE report 21044732 ↗
• MalfunctionOct 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE PICC LINE ACTUALLY KNOT WHILE BEING INSERTED. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 08 OCTOBER 2023: PICC WAS NOT KINKED OR BENT PRIOR TO INSERTION INTO VEIN. URGENT DUE TO BEING UNABLE TO REMOVE KNOTTED PICC LINE. PICC LINE KNOTTED IN PATIENT ARM WHICH REQUIRED INTERVENTIONAL RADIOLOGY TO REMOVE. DID NOT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION AS PATIENT HAD OTHER IV ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17896047 ↗
• MalfunctionAug 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT LEAKAGE FOUND AT THE INSERTION SITE. PATIENT COMPLAINED OF BURNING AT THE SITE. EVALUATED AND FOUND LEAK AT THE 2CM MARK JUST BELOW THE SKIN LEVEL AT THE INSERTION SITE. REMOVED. RESPONSE RECEIVED 27 JULY 2023: THE EVENT DID NOT INVOLVE AN URGENT OR LIFE-THREATENING MEDICAL SITUATION, CAUSE A CLINICALLY SIGNIFICANT DELAY IN TREATMENT, INTERRUPTION IN TREATMENT, AND CAUSED NO HARM TO THE PATIENT. PATIENT WAS RECEIVING OR PLANNED TO RECEIVE CEFAZOLIN.

  Patient problems: Skin Burning Sensation

  MAUDE report 17450402 ↗