PowerPICC HF Catheter with Sherlock Tip Location System (TLS) Stylet 9385108QDRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741035807), received between Nov 3, 2015 and Dec 8, 2016 — classified as 2 injuries, 2 malfunctions.

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

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

• InjuryDec 8, 2016Difficult to Insert

  NURSE SENT IN REPORT REGARDING A 5CM POWERPICC. THEY STATED, "CAUGHT AT INSERTION, HAVING PREVIOUSLY INTRODUCED POST-INSERTION VISUAL INSPECTION". THE PATIENT WAS SENT TO IR FOR RETRIEVAL. NO OTHER INFORMATION PROVIDED BY THE FACILITY. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6154575 ↗
• MalfunctionNov 14, 2016Detachment Of Device Component

  PICC LINE INSERTION PROCEDURE WAS PERFORMED ON PT VIA LUE. ACCESS TO VEIN (BRACHIAL) WAS SUCCESSFUL VIA SAFETY NEEDLE. GUIDEWIRE INSERTED WITHOUT ANY RESISTANCE INTRODUCER WAS PLACED. POWER PICC 55CM 5F WAS THEN TRIMMED 10CM. THE STYLET WAS PULLED BACK TO THE TRIMMED LENGTH OF THE CATHETER WITH MAGNET TIP INTACT AND INSIDE THE CATHETER. POWER PICC CATHETER WAS INSERTED THRU THE INTRODUCER. WHILE TRYING TO ADVANCE CATHETER, PAST MIDCLAVICULAR REGION. DECISION TO ABORT PROCEDURE WAS MADE AND CATHETER WAS PULLED OUT AND INSPECTED. AT THIS TIME, IT WAS NOTED THAT THE STYLET DID NOT HAVE A MAGNET TIP INTACT. PT WAS TAKEN TO IR, BUT REMOVAL OF RETAINED STYLET TIP WAS UNSUCCESSFUL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6106165 ↗
• InjuryJul 19, 2016Break

  ON 07/06/2016- PER SALES REPRESENTATIVE THE FACILITY REPORTED THAT ON (B)(6) 2016 THE PICC WAS INSERTED VIA THE RIGHT CEPHALIC VEIN. THE PICC WAS TRIMMED 10CM AND POSITIONED AT THE 42CM MARK. THE CHEST X-RAY TAKEN ON (B)(6) 2016 SHOWED APPROPRIATE POSITION FOR THE PICC TIP. IT WAS STATED THAT ON (B)(6) 2016 RADIOLOGY NOTED A THIN METALLIC OBJECT APPROXIMATELY 3CM AT LEVEL OF RIGHT AXILLARY VEIN. THE OBJECT WAS REMOVED AND DISCARDED BY INTERVENTIONAL RADIOLOGY ON (B)(6) 2016. A PHOTO WAS TAKEN OF THE OBJECT AND THE RADIOLOGIST REPORTEDLY DETERMINED IT TO BE CONSISTENT WITH TIP OF STYLET USED WITH THE TYPE OF PICC INSERTED.

  Patient problems: No Code Available

  MAUDE report 5806743 ↗
• MalfunctionNov 3, 2015Material Frayed

  PER SALES REPRESENTATIVE, A CUSTOMER REPORTED THAT MIDWAY THROUGH A PROCEDURE THE WIRE ALLEGEDLY BECAME FRAYED AND WAS PULLED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5199375 ↗