PowerPICC Catheter with Sherlock Tip Positioning System (TPS) Stylet 9174108Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741035548), received between May 6, 2016 and Nov 4, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "PICCS ARE LEAKING AROUND THE SUTURE WING AND THE HUB."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735819 ↗
• InjuryApr 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE PATIENT WAS LEAVING THE FACILITY SHE COMPLAINED OF PAIN IN HER LEFT ARM. UNDER ULTRASOUND IT WAS NOTED THAT THE PATIENT HAD DVT IN THE LEFT ARM. PICC WAS PLACED IN THE LEFT BASILIC VEIN. PATIENT IS CURRENTLY RECEIVING ANTIBIOTIC THERAPY.

  Patient problems: Pain; Thrombosis

  MAUDE report 6513556 ↗
• MalfunctionDec 1, 2016Device Or Device Fragments Location Unknown

  FACILITY REPORTED TO THE SALES REPRESENTATIVE THAT AFTER THE PICC WAS INSERTED AND THE WIRE WAS REMOVED AND EXAMINED, THE HEALTHCARE PROFESSIONAL FOUND THAT THE LAST 3+CMS WAS MISSING. A STAT CHEST X-RAY WAS OBTAINED AND THE WIRE WAS NOT SEEN. THE EQUIPMENT WAS EXAMINED AND THE WIRE WAS NOT FOUND. THE PIECE CUT AWAY, THE TOWELS AND DRAPES, SYRINGES USED, THE NEEDLE BOX AND THE FLOOR OF THE PATIENT'S ROOM WAS ALSO SEARCHED. THERE WAS BLOOD WORK DRAWN AS SOON AS THE WIRE WAS REMOVED BUT THE LAB COULD NOT CHECK THE TUBES. THE PATIENT HAD A CT DONE ON RE-ADMISSION AND NOTHING WAS SEEN IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6139746 ↗
• MalfunctionMay 6, 2016Break

  ON (B)(6) 2016-PER SALES REPRESENTATIVE, USER FACILITY REPORTED THAT THE TIP OF THE DILATOR BROKE OFF DURING INSERTION. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5638179 ↗