Pro-PICC® CT MR17034101Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884908033069), received between Mar 14, 2018 and May 8, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 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.

• MalfunctionMay 8, 2024Leak/Splash; Leak/Splash

  EXTRAVASATION OF SOLUTION THROUGH THE OSTIUM. THE PATIENT WAS PUNCTURED ON (B)(6) 2024. ON (B)(6) 2024, EXTRAVASATION WAS NOTICED DUE TO MOISTURE IN THE DRESSING. ON (B)(6) 2024, THE INSERTION NURSE ASSESSED AND REMOVED THE CATHETER. THERE WAS NO NEED FOR A NEW PUNCTURE. PATIENT WAS DISCHARGED HOME.

  Patient problems: Extravasation

  MAUDE report 19269183 ↗
• MalfunctionMay 8, 2024Leak/Splash; Leak/Splash

  EXTRAVASATION OF SOLUTION THROUGH THE OSTIUM. ON (B)(6) 2024 THE PROCEDURE WAS CARRIED OUT. THE OCCURRENCE WAS NOTICED ON THE SAME NIGHT OF INSERTION, THROUGH THE NEED FOR NUMEROUS DRESSING CHANGES DUE TO HUMIDITY. ON (B)(6) 2024, THE CATHETER WAS EVALUATED BY THE INSERTION TEAM AND HAD TO BE REMOVED. NEW ACCESS WAS PERFORMED

  Patient problems: Extravasation

  MAUDE report 19269098 ↗
• MalfunctionJul 1, 2021Leak/Splash; Leak/Splash

  CATHETER IS LEAKING AND MACERATED AFTER DAYS OF INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 12098950 ↗
• MalfunctionJul 30, 2020Leak/Splash; Leak/Splash

  AFTER IMPLANTATION IT WAS NOT POSSIBLE TO FLUSH AND NOT ASPIRATE BLOOD. WHEN THE CATHETER WAS FLUSHED, LIQUID CAME OUT FROM THE PUNCTURE SITE. THE DOCTOR PULLED THE PICC. THE PICC HAS A SPLIT AFTER 5-6 CM FROM THE PUNCTURE SITE TOWARDS THE HEART. THE DOCTOR IMPLANTED A NEW PICC FROM THE SAME PUNCTURE SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10344266 ↗
• InjuryMar 7, 2019Difficult to Remove; Difficult to Remove

  DURING PLACEMENT OF THE PICC, A KNOT AROSE IN THE GUIDEWIRE. THE VESSEL WAS SMOOTHLY PUNCTURED AND THE GUIDEWIRE INTRODUCED, INITIALLY TAKING THE JUGULAR PATHWAY. THE GUIDEWIRE CURLED BACK IN SEVERAL DIRECTIONS AND EVENTUALLY A KNOT AROSE. THE WIRE GOT STUCK IN THE VEIN APPROXIMATELY 10 CM PROXIMAL FROM THE PUNCTURE SIDE. THE WIRE WAS EVENTUALLY PULLED FROM THE VESSEL, CAUSING DAMAGE TO THE BASILICA VEIN A NEW GUIDEWIRE AND DILATOR WERE OPENED AND USED TO PLACE THE PICC IN ANOTHER VEIN.

  Patient problems: Pain

  MAUDE report 8398444 ↗
• MalfunctionMar 14, 2018Knotted; Knotted

  THE VESSEL WAS SMOOTHLY PUNCTURED AND THE GUIDEWIRE WAS INTRODUCED. THERE WAS A LITTLE BIT OF RESISTANCE. THEY TRIED TO RETRACT THE GUIDEWIRE IN ORDER TO REPOSITION THE NEEDLE A LITTLE BIT CLOSER TO THE VESSEL, BUT THE GUIDEWIRE WOULDN'T RETRACT. THE NEEDLE WAS REMOVED, BUT THE GUIDEWIRE WAS STUCK IN THE SUBCUTANEOUS FAT TISSUE OF THE PATIENT. A SMALL INCISION WAS MADE IN ORDER TO REMOVE THE KNOTTED GUIDEWIRE.

  Patient problems: Pain

  MAUDE report 7337240 ↗