PowerPICC CK000757Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741141133), received between May 3, 2024 and Dec 7, 2024 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDWATCH THAT POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM WAS INSERTED PRIOR TO PATIENT'S DISCHARGE HOME WITH HOME ANTIBIOTIC INFUSIONS. PATIENT RETURNED WITH COMPLAINS OF LEAKING AND TENDERNESS AT PICC SITE, PICC LINE WAS PULLED OUT 7 CM IN COMPARISON TO ORIGINAL INSERTION MEASUREMENTS AT 2 CM. PICC WAS REMOVED AND A SLIT WAS FOUND IN THE PICC LINE TUBING AT JUST OUTSIDE THE 7 CM MARK. DUE TO LAPS IN TIME FROM INSERTION TO PATIENT RETURN, PACKAGING WAS DISCARDED AND THE LOT NUMBER IS NOT AVAILABLE. UNKNOWN HOW PATIENT CARED FOR DEVICE AT HOME PRIOR TO RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20873944 ↗
• InjuryMay 3, 2024Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, "ON (B)(6) 2024 A PATIENT CAME TO THE ER FOR PICC ASSESSMENT. THE PICC LINE WAS PLACED ON (B)(6) 2024 AND WAS LEFT EXPOSED AT 0 CM. THE PATIENT STATED THAT HE HAD NOTICED SWELLING UNDER THE SKIN NEAR THE INSERTION SITE WHEN FLUSHING. THE HOME HEALTH RN DECIDED TO PULL THE CATHETER OUT 3 CM AND THEN NOTICED THE CRACK. HE ARRIVED IN THE ER, AND AT THAT TIME I REMOVED THE PICC LINE. WHEN I ATTEMPTED TO FLUSH THE CATHETER POST REMOVAL, A BLOOD CLOT WAS DISLODGED FROM THE TIP OF THE CATHETER MEASURING AROUND AN INCH. THE PATIENT ALSO STATED TO ME THAT HIS LINE HAD BECOME DIFFICULT TO FLUSH ¿ BUT STATED THAT HE DID NOT THINK HE APPLIED EXCESSIVE PRESSURE WHILE ATTEMPTING TO FLUSH." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 19239835 ↗