PowerPICC SOLO2 Catheter with Sherlock Tip Location System (TLS) Stylet 9396108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741035937), received between May 15, 2017 and Jun 29, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2018Material Fragmentation

  IT WAS REPORTED THAT DURING PICC INSERTION IT WAS DISCOVERED THAT PART OF THE SHERLOCK GUIDEWIRE WAS MISSING. A CHEST X-RAY REVEALED WIRE FRAGMENT IN PATIENTS RIGHT UPPER SHOULDER AREA. THIS WAS A WIRE FRAGMENT THAT BROKE OFF FROM THE SHERLOCK TLS GUIDEWIRE. THE PATIENT REQUIRED TWO SEPARATE INTERVENTIONAL RADIOLOGY PROCEDURES TO SAFELY RETRIEVE THE BROKEN WIRE. IT WAS REPORTED THAT THERE WAS NO LASTING HARM TO PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7651911 ↗
• MalfunctionAug 17, 2017Unraveled Material

  IT WAS REPORTED BY THE FACILITY THAT THE NURSE HAD AN ISSUE WITH THE MICROEZ INTRODUCER NEEDLE IN THE PATIENT, WHEN RETRACTING THE NEEDLE, THE GUIDEWIRE UNRAVELED.

  Patient problems: No Information

  MAUDE report 6800187 ↗
• MalfunctionMay 15, 2017Entrapment of Device; Difficult to Remove

  THE FACILITY REPORTED THAT THEY ARE EXPERIENCING DIFFICULTY INSERTING AND WITHDRAWING THE GUIDEWIRE. ONCE THE GUIDEWIRE IS INSERTED THROUGH THE NEEDLE GUIDE THE WIRE ¿GETS STUCK¿ AND THE HEALTHCARE PROFESSIONAL (HCP) IS UNABLE TO WITHDRAW UNLESS THE GUIDEWIRE AND THE NEEDLE ARE REMOVED TOGETHER. AFTER THE DEVICE WAS REMOVED THE HCP WAS STILL NOT ABLE TO WITHDRAW THE GUIDEWIRE FROM THE NEEDLE, AS IF THERE WAS A ¿KNOT IN THE WIRE¿. HCP USED A MICRO-EZ AND GUIDEWIRE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6568027 ↗