PowerPICC Catheter with Sherlock Tip Location System (TLS) Stylet 9174108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741035555), received between Apr 7, 2017 and May 15, 2025 — classified as 5 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.

• MalfunctionMay 15, 2025Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  ADDITIONAL INFORMATION RECEIVED ON 21-MAY-2025: DURING THE PROCEDURE. THE NURSE HAD THREADED THE LINE. WHEN SHE WENT TO "PEEL" AWAY THE SHEATH THE ORANGE PORTION ON ONE SIDE SNAPPED OFF INTO HER HAND. THE NURSE WAS ABLE TO CAREFULLY REMOVE THE REST OF THE INTRODUCER FROM THE PATIENT. NO PORTION WAS RETAINED. NO HARM AND NO INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031931 ↗
• MalfunctionMar 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "BLOOD RETURN NOTED ON FLOW SHEETS FOR MULTIPLE DAYS. NO TPA ADMINISTRATIONS OR POWER INJECTIONS NOTED IN CHART. PATIENT REQUIRED NO ADDITIONAL TREATMENT OR INTERVENTION ONCE LINE REMOVED. UPON REMOVAL, TEAR IN EXTERNAL PORTION OF THE LINE BETWEEN 35-40CM MARKINGS. THE TEAR SEEMS TO BE 5CM LONG."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542239 ↗
• MalfunctionNov 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POWERPICC WAS FOUND LEAKING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9354482 ↗
• MalfunctionNov 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POWERPICC WAS FOUND LEAKING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349486 ↗
• MalfunctionApr 7, 2017Air Leak; Leak/Splash; Connection Problem

  PER SALES REP, THE PRIMARY NURSE AT THE FACILITY STATED THE PICC LINE WAS LEAKING AT THE HUB TUBING CONNECTION. IT WAS REPORTED THAT THE RN NOTED AIR IN THE LINE WHEN TRYING TO DRAW BLOOD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6474185 ↗