PowerPICC® SV Catheter with Sherlock Tip Location System (TLS) Stylet 9173108Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741028564), received between Apr 26, 2017 and Dec 11, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED SHERLOCK STYLET IS KINKING AND SEE THAT DURING REMOVAL OF STYLET AFTER INSERTION. NO PATIENT HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20908734 ↗
• MalfunctionNov 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER PICC LEAKING/RUPTURING IN THE AREA WHERE THE CATHETER CONNECTS TO THE SUTURE WING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756954 ↗
• MalfunctionNov 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER PICC LEAKING/RUPTURING WHERE THE EXTENSION LEG CONNECTS TO THE HUB. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756315 ↗
• 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 15736767 ↗
• MalfunctionOct 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "INTRODUCER SHEATH WHERE THE SHEATH MEETS THE DILATOR IS ROLLING UP UPON ATTEMPTED ENTRY, CAUSING INABILITY TO ENTER VESSEL"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633303 ↗
• InjuryApr 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY HEALTH PROFESSIONAL "PATIENT WITH LINE AT HOME FOR TREATMENT. PATIENT INFORMED MOTHER ¿ARM FELT WET¿, MOTHER INITIALLY THOUGHT CAP LOOSE, SO SHE TIGHTENED MORE. A FEW MINUTES LATER, PATIENT INFORMED MOM, STILL WET. MOTHER OBSERVED LEAKING AT DISTAL END OF TUBING WHERE CAP ATTACHES. MOTHER THEN CALLED CLINIC WHO INSTRUCTED MOTHER TO GO TO ER. MILRINONE STILL INFUSING. UPON EXAM IN ER, THIS RN THEN OBSERVED LEAKING AT STATED SITE. DISCUSSED WITH MEDICAL TEAM. PICC WAS LOCKED OFF, PIV STARTED FOR MILRINONE, AND PATIENT ADMITTED FOR PICC REPLACEMENT THE NEXT DAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694119 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED THAT THE SV PICC LINE WAS PLACED ON (B)(6) 2020 AND BROKE ON (B)(6) 2020. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10615104 ↗
• MalfunctionJul 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED HOME HEALTH CAME TO PT'S HOUSE AND PICC WOULD FLUSH BUT NOT DRAW BLOOD. IT WAS STATED THE PATIENT'S SHIRT WAS WET SO BROUGHT HIM TO THE HOSPITAL VIA THE ER ON 6/16 AND THERE WAS A HOLE IDENTIFIED IN THE CATHETER WHERE THE HUB AND EXTENSION LEG MEET. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10259008 ↗
• MalfunctionDec 5, 2019Crack; Crack

  IT WAS REPORTED THAT THE BLUE PORT CRACKED AT THE CONNECTION SITE. ON 11/26/2019-ADDITIONAL INFORMATION: "THE LINE WAS DC'D FROM THE PATIENT AND THROWN AWAY. THERE WAS NO KNOWN PATIENT HARM. NO KNOWN INFECTIOUS DISEASE. THE CONNECTION AT THE LINE AND THE BLUE CAP WAS NOTED TO BE CRACKED AND LEAKING."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417907 ↗
• InjuryMay 1, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PICC LINE WAS PLACED IN 2018. IT WAS STATED THAT A METALLIC STRUCTURE WHICH PROJECTS OVER THE RIGHT PROXIMAL FEMUR WAS IDENTIFIED DURING A KUB SCAN. USING ULTRASOUND, THE LINEAR HYPOECHOIC STRUCTURE WAS CONFIRMED IN THE ANTERIOR MUSCULATURE OF THE PROXIMAL RIGHT THIGH, ASSUMED TO REPRESENT A FOREIGN BODY 1.3CM LONG AND 5-9MM DEEP INTO THE SKIN. DOPPLER CONFIRMED THE FOREIGN BODY TO BE EXTRAVASCULAR.

  Patient problems: Foreign Body In Patient

  MAUDE report 7478339 ↗
• MalfunctionApr 26, 2017Device Contamination with Chemical or Other Material

  THE FACILITY REPORTED TO THE SALES REP THAT THE TRAY WAS OPENED IN THE O.R., AS THE PRODUCTS WERE BEING REMOVED FROM THE TRAY IT WAS VISUALIZED THAT A HAIR WAS PACKAGED BETWEEN THE BLUE WRAP AND THE TRAY. THE KIT WAS DISCARDED AND A NEW KIT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6524723 ↗