PowerPICC SOLO2 FT Catheter 3295355FRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741028151), received between May 10, 2017 and Apr 11, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Backflow” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED BY THE CUSTOMER "PATIENTS CODING OR SHORTNESS OF BREATHE AFTER PLACING PICC LINE IN IR SUITE". NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Cardiac Arrest; Dyspnea

  MAUDE report 16715849 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER "PATIENT CODED OR HAD SHORTNESS OF BREATHE AFTER PLACING PICC LINE IN IR SUITE". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Dyspnea

  MAUDE report 16715490 ↗
• MalfunctionJan 14, 2020Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC WAS LEAKING BLOOD AND IT NEEDED TO BE REPLACED. IT WAS STATE THE USER WAS QUESTIONING THE VALVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587924 ↗
• MalfunctionOct 12, 2017Difficult to Advance

  IT WAS REPORTED BY THE FACILITY THAT DURING PLACEMENT THE GUIDEWIRE WAS INSERTED INTO THE INTRODUCER AND THE GUIDEWIRE WOULD NOT GO PAST THE NEEDLE. GUIDEWIRE WAS REMOVED AND THE END APPEARED TO BE "MANGLED". OPENED ANOTHER KIT THE FACILITY HAD IN STOCK AND USED THE GUIDEWIRE FROM THAT KIT TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6945121 ↗
• MalfunctionMay 10, 2017Failure to Prime

  IT WAS REPORTED BY THE FACILITY THAT AFTER THE PICC WAS INSERTED THEY WERE UNABLE TO FLUSH THE DEVICE. IT WAS STATED THAT WHEN THE RN TRIED TO PUT THE WIRE BACK THROUGH, IT WOULD NOT INSERT INTO THE DEVICE. THE PICC WAS REMOVED AND THEY ATTEMPTED TO FLUSH THE DEVICE AND WERE UNSUCCESSFUL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6556609 ↗