PowerPICC SOLO2 Catheter with Sherlock Tip Location System (TLS) Stylet 9295108Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741028649), received between Aug 17, 2018 and Oct 5, 2018 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2018Break; Fitting Problem

  IT WAS REPORTED THAT THE PICC PLACEMENT OCCURRED ON (B)(6) AND A WIRE FRAGMENT WAS FOUND UNDER X-RAY ON (B)(6). IT WAS STATED THERE WERE NO FRAGMENTS FOUND WITH THE INITIAL X-RAYS. FOUR DAYS LATER , FRAGMENTS OF A WIRE WERE FOUND UNDER X-RAY. THE WIRE WAS FOUND ZIG -ZAGGING UNDER THE PULMONARY ARTERY. IT WAS STATED THAT THE FACILITY IS NOT 100% SURE IF IT IS FROM THE PICC INSERTION SINCE THE PICC NURSE DIDN¿T OBSERVE ANYTHING UNUSUAL. ACCORDING TO THE PICC NURSE, THE PICC PROCEDURE WAS TYPICAL AND THE PATIENT WAS NOT CONSIDERED A DIFFICULT STICK. THE PATIENT WAS NOT IN ANY PAIN. THE FRAGMENT WAS NOT REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7939654 ↗
• MalfunctionAug 17, 2018Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE CATHETER WAS VERY DIFFICULT TO REMOVE AFTER AN ATTEMPT TO PLACE IT. IT WAS STATED ONCE THE PHYSICIAN HAD REMOVED IT, A KNOT IN THE CATHETER WAS NOTED. NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794749 ↗