PowerPICC SOLO2 FT Catheter 3295108FDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741028076), received between Mar 5, 2021 and Dec 12, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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.

• MalfunctionDec 12, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER, CATHETER NOT POWER FLUSHING WHEN IT FLIPS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919615 ↗
• MalfunctionNov 20, 2023Material Deformation; Material Deformation

  CUSTOMER STATED THAT GUIDEWIRE COILS WHEN BEING INSERTED INTO PATIENT. SHE STATED THIS HAS HAPPENED SEVERAL TIMES, BUT DOES NOT KNOW HOW MANY TIMES OR SPECIFIC DATES. ADDITIONAL INFORMATION PROVIDED 10/30/2023: AFTER GUIDEWIRE COILS, IT MAY OR MAY NOT BE ABLE TO BE USED; MULTIPLE OCCASIONS OF OPENING A SECOND KIT TO REPLACE THE GUIDEWIRE WHICH CAUSES A DELAY OF ACCESS. EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. EXTENDED TIME FOR INSERTION DUE TO DIFFICULTY AND HAVING TO OPEN ANOTHER KIT. MULTIPLE KITS HAD TO BE USED. NO PATIENTS HARMED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175572 ↗
• MalfunctionNov 20, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT GUIDEWIRE COILS WHEN BEING INSERTED INTO PATIENT. ADDITIONAL INFORMATION PROVIDED 10/30/2023: AFTER GUIDEWIRE COILS, IT MAY OR MAY NOT BE ABLE TO BE USED; OPENING A SECOND KIT TO REPLACE THE GUIDEWIRE WHICH CAUSES A DELAY OF ACCESS. THIS DID NOT CAUSE AN URGENT SITUATION, BUT EXTENDED TIME FOR INSERTION DUE TO DIFFICULTY AND HAVING TO OPEN ANOTHER KIT. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173890 ↗
• MalfunctionAug 31, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "OUR INFUSION NURSE WAS INSERTING A PICC THIS MORNING THAT HAD A FAULTY INTRODUCER; THE END IS ROLLED JUST SLIGHTLY. THEY HAD TO OPEN ANOTHER KIT TO COMPLETE PROCEDURE." NO OTHER INFORMATION WAS PROVIDED. (B)(6) 2021: DURING EVALUATION THE RETURNED DEVICE WAS NOTED TO BE CRUMPLED AT THE DISTAL EDGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392011 ↗
• MalfunctionJul 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED A FAULTY INTRODUCER. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12254993 ↗
• InjuryMar 5, 2021Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "ATTEMPTED TO INSERT PICC LINE IN LUE, ENCOUNTERED SOME RESISTANCE ON THE SUBCLAVIAN REGION WHEN ATTEMPTING TO ADVANCE LINE. PULLED LINE BACK APPROXIMATELY 10 CM, FLUSHED THE LINE AMD ATTEMPTED TO ADVANCE. WHEN THAT ATTEMPT FAILED, THE LINE WAS REMOVED AND PICC WAS PLACED IN THE RIGHT ARM. CHEST X-RAY WAS DONE AND A FOREIGN BODY, PRESUMABLY A WIRE MEASURING ABOUT 3.8CM WAS DETECTED IN THE LEFT SUBCLAVIAN REGION. THE PATIENT HAD BEEN DISCHARGED. THE PATIENT WAS INSTRUCTED TO RETURN TO THE HOSPITAL IMMEDIATELY. THE FOREIGN OBJECT WAS REMOVED ON (B)(6) 2020. "

  Patient problems: Foreign Body In Patient

  MAUDE report 11424112 ↗