PowerPICC 1174108D6Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741232152), received between Dec 19, 2025 and Apr 6, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Fluid/Blood Leak

  IT WAS REPORTED VIA MEDSUN THAT A SINGLE-LUMEN PICC LINE IN AN OUTPATIENT TODAY THAT RUPTURED AT THE 8 CM MARK DURING A CT SCAN WITH CONTRAST. IT INFILTRATED 2 SCANS WORTH OF CONTRAST INTO THE PATIENT'S ARM. THE LINE WAS PLACED BY THE PICC TEAM. THE PATIENT ARRIVED IN THE CT DEPARTMENT FOR A CT SCAN WITH AND WITHOUT CONTRAST. THE PATIENT PRESENTED WITH A POWER PICC THAT HAD BEEN IN PLACE FOR ABOUT TWO MONTHS. I FLUSHED THE PICC WITHOUT DIFFICULTY, CONNECTED THE CONTRAST INJECTOR, AND ADMINISTERED THE CONTRAST BOLUS. AFTER COMPLETING THE DIAGNOSTIC SCAN, I OBSERVED THAT NO CONTRAST WAS VISIBLE IN THE PATIENT¿S VESSELS OR HEART ON IMAGING. A BEDSIDE ASSESSMENT SHOWED THE PICC APPEARED EXTERNALLY INTACT, WITH NO VISIBLE CONTRAST LEAKAGE ON THE TABLE OR FLOOR. I OBTAINED AN AP CHEST SCOUT IMAGE, WHICH CLEARLY DEMONSTRATED THAT THE CONTRAST BOLUS HAD EXTRAVASATED INTO THE PATIENT¿S ARM, CONFIRMING PICC FAILURE. I NOTIFIED NURSING AND RADIOLOGY. ICE AND ELEVATION WERE APPLIED, AND THE PATIENT WAS INSTRUCTED ON SIGNS AND SYMPTOMS OF CONTRAST EXTRAVASATION. DR. ASSESSED THE PATIENT AND RECOMMENDED REMOVING THE PICC TO ENSURE THE ENTIRE CATHETER WAS INTACT. RN CONTACTED THE PROVIDER AND OBT

  Patient problems: Extravasation

  MAUDE report 24790012 ↗
• MalfunctionMar 31, 2026Product Quality Problem; Material Deformation

  IT WAS REPORTED VIA MEDSUN THAT THE PICC WAS SECURED WITH SECURACATH. DURING REMOVAL, IT WAS NOTED THE PICC WAS "IMPRESSIVELY DEFORMED WHERE THE WITHIN THE SECURACATH COMPRESSION AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744020 ↗
• MalfunctionFeb 18, 2026Activation Problem

  IT WAS REPORTED THE GREEN NEEDLE INSIDE OF THEIR KIT THIS PAST WEEK HAD A FAULTY SAFETY DEVICE. THE GREEN TIP SLID RIGHT OFF OF THE NEEDLE AND DID NOT STOP AT THE TIP. NO ONE WAS INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378845 ↗
• MalfunctionFeb 18, 2026Activation Problem

  IT WAS REPORTED THE GREEN NEEDLE INSIDE OF THEIR KIT THIS PAST WEEK HAD A FAULTY SAFETY DEVICE. THE GREEN TIP SLID RIGHT OFF OF THE NEEDLE AND DID NOT STOP AT THE TIP. NO ONE WAS INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378826 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak

  IT WAS REPORTED 4F SL PICC HAS HOLE INSIDE PATIENT ARM, STATLOCK USED. PICC WAS PULLED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308741 ↗
• MalfunctionJan 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT HOLE IN PICC AT 6CM MARK. THE LINE HAD TO BE PULLED 60 DAYS AFTER PLACEMENT DUE TO THE HOLE IN THE LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039835 ↗
• MalfunctionDec 19, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THE INTRODUCER NOT BREAKING AWAY AS ANTICIPATED TO EXPOSE THE CATHETER. PROCEEDED TO CUT THE INTRODUCER WITH A SCALPEL TO FINISH PROCEDURE. POWER FLUSHED THE LINE AND INSPECTED THE EXPOSED CATHETER PRIOR TO INSERTING TO VERIFY ITS FUNCTIONALITY AND VISUALIZED NO ISSUES WITH THE CATHETER ITSELF. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851491 ↗