PowerPICC Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 1275108Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741034541), received between Dec 31, 2015 and Apr 22, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "DOUBLE LUMEN PICC LINE, ONE OF THE TWO LUMENS DEVELOPED A LEAK IN THE CATHETER PRODUCT WAS USED WITH 5 FRENCH SECURACATH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189081 ↗
• MalfunctionSep 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "I PLACED A 2L 5 FRENCH POWER PICC AND LATER IN THE DAY IT WAS REMOVED BECAUSE IT WAS LEAKING. A SMALL SPLIT IS SEEN AT THE 3 CM MARK." MEDWATCH RECEIVED (B)(6)2020: "BARD PICC DEVELOPED LEAK IN THE CATHETER SEVERAL HOURS AFTER PLACEMENT. IT WAS PROMPTLY REMOVED. A SMALL SPLIT IN THE PICC AT APPROX. 3 CM MARK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10489356 ↗
• MalfunctionJan 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PURPLE LUMEN ON POWERPICC WAS NOTED TO BE CRACKED WHEN FLUSHING, SALINE COMING OUT OF OPENING. PICC LINE WAS PULLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9548511 ↗
• MalfunctionDec 9, 2016Crack; Fluid/Blood Leak

  IT WAS REPORTED BY THE FACILITY THAT A CATHETER WAS FOUND TO HAVE HAD A CRACK IN THE SIDE OF IT AT 7CM FROM THE HUB. IT HAD 2CM EXTERNAL CATHETER LENGTH AND HAD BEEN DWELLING FOR 5 DAYS. IT PRESENTED AS MEDICATION LEAKING OUT THE INSERTION SITE. NURSE REPORTED THEY CAN COME UP WITH NO EXPLANATION FOR WHY THE CATHETER DEVELOPED A CRACK 5CM UP FROM THE INSERTION. NO HARM TO PATIENT, PICC WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6157936 ↗
• MalfunctionDec 31, 2015Break

  PER SALES REPRESENTATIVE, FACILITY REPORTED THAT A NURSE IMPLANTED A PICC LINE IN PATIENT EARLY MORNING AT THE END OF THEIR SHIFT AND THEN WENT HOME. NURSE REPORTED LATER THAT A BIT OF WIRE WAS LEFT IN THE PATIENT. AN X-RAY WAS SAID TO HAVE BEEN TAKEN AND THE WIRE WAS REMOVED FROM THE PATIENT'S RIGHT AXILLARY VEIN. NO PATIENT HARM REPORTED. THE PICC LINE WAS REMOVED AND NO NEW LINE WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5338976 ↗