PowerPICC® Catheter 3174108Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741027574), received between Feb 2, 2018 and Jun 24, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 11, 2025Class IOpen, 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 · Recall details · 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.

• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PATIENT HAD DISCOMFORT WHEN PICC LINE WAS FLUSHED AND DIFFICULTY WITH FLUSHING. PICC LINE WAS REMOVED AND A CRACK WAS NOTICED IN THE TUBING THAT WAS AT THE AREA WHERE THE PATIENT WAS HAVING DISCOMFORT.

  Patient problems: Pain

  MAUDE report 22320762 ↗
• MalfunctionSep 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER " DURING REMOVAL OF A PICC LINE FROM A PATIENT THE LINE WAS INSPECTED AND NOTED TO HAVE TEAR IN THE CATHETER WALL AROUND THE 30 CM MARK. THE TEAR WAS APPROXIMATELY 1 CM IN LENGTH AND THE END OF THE CATHETER WAS INTACT. IT DID NOT APPEAR THAT ANY OF THE CATHETER WAS RETAINED WITHIN THE PATIENT, NO HARM TO THE PATIENT WAS IDENTIFIED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15385087 ↗
• MalfunctionSep 4, 2019Break; Device Dislodged or Dislocated; Break

  IT WAS REPORTED THAT NURSE LET PATIENT ALONE FOR 5 MINUTES AND WHEN SHE RETURNED TO THE ROOM THERE WAS BLOOD EVERYWHERE. SHE STATED IT LOOKED LIKE THE PATIENT PULLED ON HIS CATHETER SO HARD THAT IT SNAPPED A CLEAN CUT. IT WAS REPORTED THAT THERE IS A VISIBLE WHITE LINE LIKE THE CATHETER WAS DISTRESSED. THE CATHETER WAS FULLY INTACT WITH THE SECURCATH.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 8960030 ↗
• MalfunctionAug 1, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT 4 FR SINGLE LUMEN POWERPICC WAS PLACED IN THE RIGHT ARM, BRACHIAL VEIN; 5 CM EXTERNAL LENGTH, SECURACATH IN PLACE. ON (B)(6) 2019, VASCULAR ACCESS TEAM WAS CALLED TO ASSESS 4FR SINGLE LUMEN POWER PICC TO RIGHT UPPER ARM PLACED ON (B)(6) 2019 FOR POSSIBLE LEAKING. PICC LINE FLUSHED WITH 10ML NS AND NO LEAKING NOTED. DRESSING WAS REMOVED AND BIOPATCH WAS NOTED TO BE SATURATED WITH SEROUS FLUID. ONCE THE DRESSING WAS REMOVED THE PICC WAS FLUSHED WITH 20ML NS WITH DIRECT OBSERVATION OF INSERTION SITE. NO LEAKING NOTED. THE SECURACATH WAS REMOVED TO ASSESS FOR FRACTURE AND THE PICC WAS PULLED BACK 1CM TO ASSESS FOR LEAKING. NONE NOTED. THE DRESSING WAS APPLIED. DISCUSSED WITH THE BEDSIDE RN THAT THE PICC WAS OK TO USE FOR NOW. IF THE PICC APPEARS TO BE LEAKING OR ANY OTHER CONCERNS STOP THE INFUSION AND PLACE A PIV. WILL HAVE FURTHER DISCUSSIONS IF LONG TERM ACCESS IS NEEDED. ON (B)(6) 2019, THE VASCULAR ACCESS TEAM WAS CONTACTED AGAIN DUE TO PERSISTENT LEAKING FROM THE SITE; UNKNOWN SOURCE OF LEAKAGE. PICC WAS REMOVED. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8851674 ↗
• InjuryFeb 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE VASCULAR ACCESS NURSE TO MS&S THAT HER PATIENT IS HAVING A POSSIBLE REACTION TO A POWERPICC. IT WAS STATED THAT THE PATIENT HAS CYSTIC FIBROSIS AND MULTIPLE ALLERGIES. THE PATIENT CAME IN FOR A PICC PLACEMENT ON (B)(6) 2018. THE PATIENT COMPLAINED OF PAIN SHORTLY AFTER INSERTION AND THE PAIN INTENSIFIED OVER THE NEXT DAY AND BECAME SEVERE. THE AREA AROUND THE PICC BECAME SWOLLEN, RED AND VERY ITCHY. THERE WAS A 3 CM AREA AROUND THE PICC INSERTION SITE THAT WAS VERY INFLAMED. THEY DID AN ULTRASOUND AND RULED OUT A DVT. THE PICC WAS REMOVED 01/14/18, THE REDNESS AND SWELLING ARE RESOLVING. MS&S DISCUSSED MATERIAL CONTENT OF THE POWERPICC AND HOW PATIENTS CAN ALSO REACT TO THE CHLOROHEXIDINE.

  Patient problems: Itching Sensation; Pain; Swelling

  MAUDE report 7239001 ↗