Pro-Fuse® Low Profile CT Port MRCTT80041Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908031393), received between Jan 3, 2018 and Jul 13, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Wrinkled” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  UNIQUE RIGHT SUBCLAVIAN PUNCTURE WITH NO COMPLICATIONS. GUIDEWIRE AND DILATOR PASS UNDER SELDINGER. AT THAT TIME PATIENT PRESENTS LEFT THORACIC PAIN. X-RAY REVEAL SHEATH AND DILATOR HAS PERFORATED THE VEIN AND WE FOUND LEFT HEMOTHORAX WITH EVIDENCE OF ASSOCIATED HEMOTHORAX. THORACOTOMY TUBE WAS INSERTED AND IMPLANTABLE CATHETER PROCEDURE CANCELED.

  Patient problems: Hemothorax; Perforation

  MAUDE report 7686940 ↗
• InjuryJan 3, 2018Wrinkled; Wrinkled

  RESTRICTION FOR VENOUS DILATION WHEN PASSING THE DILATOR DUE TO DAMAGE OF IT. WHEN ADVANCING THE DILATOR, THE THICKEST SHEATH WRINKLES, THE THINNEST DILATOR TEARS, SO IT IS WITHDRAWN AND A NEW SET OF PORT IS REQUESTED. NEW PUNCTURE IS PERFORMED WITH GOOD VENOUS RETURN BUT WHEN PASSING THE GUIDEWIRE AND UNDER FLUOROSCOPY VERIFICATION, DEVIATION OF THE GUIDEWIRE TO RIGHT THORAX IS NOTED. PATIENT REFERS THORACIC PAIN. THORAX X-RAY SHOWS NO EVIDENCE OF PLEURAL LEAK OR PNEUMOTHORAX BUT MEDIASTINAL ENLARGEMENT; SUSPECT OF VASCULAR LESION AT SUBCLAVIAN/SUPERIOR CAVA LEVEL. INSERTION OF PORT IS CANCELED AND URGENT THORAX AND NECK ANGIOTOMOGRAPHY IS REQUESTED. HEMOPNEUMOTHORAX DRAIN HAD TO BE PERFORMED WITH CLOSED THORACOTOMY TUBE.

  Patient problems: Hemothorax; Perforation; Pneumothorax

  MAUDE report 7161559 ↗