PowerPICC SOLO2 Catheter 3396335Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741028489), received between Jul 5, 2017 and Sep 14, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2017Break; Detachment Of Device Component

  IT WAS REPORTED BY THE FACILITY THAT A PIECE OF THE GUIDEWIRE HAD BROKEN OFF AND THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE OPERATING ROOM TO HAVE THE PIECE RETRIEVED. REPORTEDLY, THE END OF THE GUIDEWIRE APPEARED TO BE UNRAVELED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6865960 ↗
• MalfunctionJul 5, 2017Break; Material Integrity Problem

  IT WAS REPORTED THAT THE WHITE HUB OF THE TRIPLE LUMEN PICC LINE, WAS BRITTLE AND BROKE IN PIECES WHEN PICC INSERTION WAS COMPLETED IN THE DI AND THE PICC WAS GOING TO BE FLUSHED FOR A POST INSERTION CHECK. THE PATIENT PROCEDURE WAS DELAYED 30 MIN , AND THE PICC LINE NEEDED TO BE EXCHANGED AND 2ND PICC TRAY OPENED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685943 ↗