PowerPICC SOLO2 HF Catheter 3395355QRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741028380), received between May 31, 2019 and Aug 11, 2023 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, "CALLER STATES HE WAS IN THE HOSPITAL FOR ABOUT 17 DAYS WITH A POWERPICC SOLO. CALLER STATES THEY REMOVED THE PICC FIVE DAYS AGO BUT HE CAN STILL FEEL TINGLING IN TWO FINGERS AND A THUMB. RESPONSE: EXPLAINED THAT IT IS POSSIBLE THAT THE CLINICIAN HIT A NERVE DURING PICC PLACEMENT. THIS MAY RESOLVE ITSELF IN A FEW DAYS BUT IT NEEDS TO BE REPORTED TO PHYSICIAN AS SOON AS POSSIBLE. THE DOCTOR MAY WANT TO FOLLOW UP WITH TREATMENTS. RESPONSE: EXPLAINED THAT IT IS POSSIBLE THAT THE CLINICIAN HIT A NERVE DURING PICC PLACEMENT. THIS MAY RESOLVE ITSELF IN A FEW DAYS BUT IT NEEDS TO BE REPORTED TO PHYSICIAN AS SOON AS POSSIBLE. THE DOCTOR MAY WANT TO FOLLOW UP WITH TREATMENTS."

  Patient problems: Numbness

  MAUDE report 17509730 ↗
• MalfunctionDec 10, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE OF THE HUBS ON A TRIPLE LUMEN PICC BROKE AT THE EXTENSION LEG WHILE IN USE ON THE PATIENT. A NEW DEVICE WAS PLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9447682 ↗
• MalfunctionMay 31, 2019Leak/Splash

  IT WAS REPORTED THAT THE INSERTION AND VERIFICATION OF THE POWER-PICC TOOK PLACE WITHOUT PROBLEM IN THE ANGIO ROOM. THE PATIENT WAS TRANSFERRED TO THE SCAN, THE PICC WAS NOT USED AT THIS TIME. IT WAS STATED THE NURSE NOTICED A LEAK ON THE CATHETER UNDER THE PART OF THE WINGS. THE PATIENT WAS RETURNED TO ANGIO TO REPLACE THE PICC. CONSEQUENCE: TREATMENT TIMES FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8658944 ↗