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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741035784), received between May 19, 2016 and Apr 14, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• InjuryApr 14, 2017Migration or Expulsion of Device

  IT WAS REPORTED VIA MEDWATCH THAT WHILE THE INTRODUCER WAS BEING PLACED AT THE INSERTION SITE AND OVER THE GUIDEWIRE, THE NURSE ATTEMPTED TO INSERT THE INTRODUCER TWICE. ON THE THIRD ATTEMPT AND THE SECOND NICK TO WIDEN THE INSERTION SITE, SHE REALIZED THE GUIDEWIRE HAD MIGRATED INSIDE THE PATIENT. SHE COULD FEEL THE VERY END OF THE GUIDEWIRE AND STOPPED THE PROCEDURE. THIS DEVICE DOES NOT INCLUDE ANY TYPE OF GUIDEWIRE CLIP IDENTIFICATION THAT COULD BE PLACED AT THE END OF THE WIRE TO ASSIST WITH MONITORING THE STATUS OF THE GUIDEWIRE WHILE ATTEMPTING TO PLACE THE INTRODUCER OR PREVENTING IT FROM MIGRATING DURING THIS PROCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 6494711 ↗
• MalfunctionMay 19, 2016Difficult to Advance

  ON (B)(6) 2016 - PER (B)(6), A RISK MANAGER CALLED TO REPORT A COMPLAINT REGARDING A POWERPICC SOLO2. CONTACT STATED THAT A NURSE INSERTED THE GUIDEWIRE BUT IT WOULD NOT ADVANCE. SHE TRIED TO REMOVE IT BUT STOPPED WHEN RESISTANCE WAS MET. ANOTHER NURSE WAS CALLED FOR ASSISTANCE WHO THEN USED A DILATOR TO DILATE THE SKIN AND WAS ABLE TO REMOVE THE GUIDEWIRE. NURSE STATED THAT THE TIP "LOOKED LIKE IT WAS TIED IN A KNOT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5668474 ↗