PowerPICC SOLO2 HF Catheter 3395335QRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741028373), received between Mar 2, 2018 and Jul 30, 2021 — classified as 1 death, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2021Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED APPARENTLY DURING THE CASE THEY FED THE GUIDE WIRE IN THROUGH THE INTRODUCER. UPON TRYING TO REMOVE GUIDE WIRE THE RADIOLOGIST WAS NOT ABLE TO PULL IT BACK THROUGH THE INTRODUCER AND HAD TO REMOVE THE INTRODUCER TO PULL GUIDE WIRE OUT. ONCE REMOVED THERE WAS STILL A SMALL THREAD ATTACHED AND HE WAS ABLE TO REMOVE THE LAST BIT OF THE GUIDE WIRE. THE INTRODUCER IS STILL ATTACHED TO THE GUIDEWIRE AS THEY WERE NOT ABLE TO REMOVE THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253642 ↗
• DeathSep 17, 2020Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "RETAINED WIRE DISCOVERED ON POST POST-PROCEDURE X-RAY INSIDE PATIENT'S RIGHT VENTRICLE."

  Patient problems: Death

  MAUDE report 10548290 ↗
• MalfunctionMar 22, 2018Fracture

  IT WAS REPORTED THAT THE CATHETER FRACTURED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7364211 ↗
• MalfunctionMar 22, 2018Fracture

  IT WAS REPORTED THAT THE CATHETER FRACTURED. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7362238 ↗
• MalfunctionMar 2, 2018Sticking

  IT WAS REPORTED BY THE FACILITY THAT DURING INSERTION OF THE CATHETER THE WIRE BECAME STUCK WITHIN THE CATHETER. THE CATHETER AND WIRE WERE REMOVED AND DISCARDED. NO OTHER INFORMATION WAS PROVIDED. THIS FILE ADDRESSES THE SECOND OF TWO DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311318 ↗
• MalfunctionMar 2, 2018Entrapment of Device

  IT WAS REPORTED BY THE FACILITY THAT DURING INSERTION OF THE CATHETER THE WIRE BECAME STUCK WITHIN THE CATHETER. THE CATHETER AND WIRE WERE REMOVED AND DISCARDED. NO OTHER INFORMATION WAS PROVIDED. THIS FILE ADDRESSES THE FIRST OF TWO DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311252 ↗