Pro-Line® CT MR28037201Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908034646), received between Feb 7, 2018 and Mar 25, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2024Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A BONE MARROW TRANSPLANT. CENTRAL LINE INSERTED. BLOOD LOSS NOTED FROM TUNNEL. ULTRASOUND SHOWED RIGHT JUGULAR VEIN THROMBOSIS. CT OF THE CHEST SHOWED AN INCREASE IN DIAMETER OF THE RIGHT INTERNAL JUGULAR VEIN AND THE LUMEN IS OCCUPIED BY MATERIAL INHOMOGENEOUS, SPONTANEOUSLY HYPERDENSE ON BASAL SCANS AND IT ITS CONTEXT SMALL GAS BUBBLES, INDICATIVE OF THROMBUS. ANTICOAGULANT THERAPY STARTED WITH LOW MOLECULAR WEIGHT HEPARIN. CATHETER WAS REMOVED AND FOUND TO HAVE A FISSURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18969777 ↗
• InjuryFeb 7, 2018Leak/Splash; Leak/Splash

  THREE WEEKS POST INSERTION THE PATIENT WAS IN CT SCAN TO HAVE A CONTRAST COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DONE. UPON ADMINISTRATION OF CONTRAST, LIMITED CONTRAST WAS SEEN ON CTA. REPORTEDLY, THE POWER-LINE INFILTRATED. 100CC OF OMNI350 CONTRAST WAS INJECTED BUT AN UNKNOWN AMOUNT INFILTRATED AS SOME WAS SEEN ON CTA AND SOME LEAKED AROUND THE POWER-LINE CATHETER. PATIENT REQUIRED ADDITIONAL PROCEDURE TO REPLACE THE POWER-LINE CATHETER. REPORTEDLY THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7248894 ↗