PowerPICC® FT Catheters with Sherlock 3CG® TPS Stylet 1275108FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741034565), received between Nov 28, 2018 and Jan 13, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2021Material Frayed; Obstruction of Flow; Therapeutic or Diagnostic Output Failure; Material Frayed

  IT WAS REPORTED "MET AXILLARY OBSTRUCTION, STOPPED PROCEDURE, WITHDREW 3CG STYLET BUT COULD NOT PULL OUT, DOCTOR ASSISTED AND SUCCESSFULLY PULLED OUT GUIDEWIRE, AND IT WAS NOT INTACT".

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11167407 ↗
• MalfunctionApr 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER PLACEMENT THE PICC WAS NOTED TO BE LEAKING. THE CATHETER WAS REPLACED OVERWIRE AND PATIENT DID NOT HAD ANY OTHER COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913837 ↗
• MalfunctionNov 28, 2018Fluid/Blood Leak; Material Perforation

  PER MEDWATCH: "PATIENT HAD D/L POWERPICC INSERTED ON (B)(6) 2018. ON (B)(6) 2018 THE DEVICE STARTED TO LEAK UNDER THE DRESSING AND WAS REPLACED ON (B)(6) 2018. EACH LUMEN WAS ALLEGEDLY FOUND TO BE LEAKING CLOSE TO THE HUB FROM PERFORATIONS IN THE CATHETER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8111556 ↗