Pro-Flo XT™ 010242Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994942807), received between Dec 19, 2016 and Jul 20, 2017 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN USED A PRO-FLO DIAGNOSTIC CATHETER WHEN CROSSING A VALVE. NO DAMAGE WAS NOTED TO PACKAGING. THE CATHETER WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED WITH NO ISSUES NOTED. THE CATHETER WAS PREPPED PER IFU WITH NO ISSUES. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE CATHETER, NO RESISTANCE USED DURING INSERTION/ DELIVERY. A CLOT WAS NOTED WHEN THEY CROSSED THE VALVE AND HOOKED UP TO PRESSURE. THERE WAS NO OTHER ISSUES WITH COAGULOPATHY (CLOTTING) WITH THIS PATIENT. AN ACT WAS CARRIED OUT. RESULTS WERE 236 AND 365. THEY NOTED A DROP IN PRESSURE AND PULLED THE CATHETER BACK WHERE CLOT WAS NOTED. PATIENT WAS THERAPEUTICALLY HEPARINIZED. PATIENT IS ALIVE WITH NO REPORTED INJURY.

  Patient problems: Thrombus

  MAUDE report 6727614 ↗
• MalfunctionDec 20, 2016Partial Blockage; Partial Blockage

  THE PHYSICIAN WAS ATTEMPTING TO USE A PROFLO DIAGNOSTIC CATHETER DURING A PROCEDURE. THE CATHETER WAS FLUSHED. IT IS REPORTED THAT CLOTS FORMED WITHIN THE CATHETER ONLY, WHEN THE PROFLO CATHETER WAS IN THE PATIENT. THE DEVICE WAS NOT FLUSHED DURING USE DUE TO THE PRESENCE OF THROMBUS. NO INTERVENTION WAS CARRIED OUT. NO ADVERSE EVENT WAS CAUSED TO THE PATIENT AS A RESULT.

  Patient problems: Thrombus

  MAUDE report 6188467 ↗
• MalfunctionDec 20, 2016Partial Blockage; Partial Blockage

  THE PHYSICIAN WAS ATTEMPTING TO USE A PROFLO DIAGNOSTIC CATHETER DURING A PROCEDURE. THE CATHETER WAS FLUSHED. IT IS REPORTED THAT CLOTS FORMED WITHIN THE CATHETER ONLY, WHEN THE PROFLO CATHETER WAS IN THE PATIENT. THE DEVICE WAS NOT FLUSHED DURING USE DUE TO THE PRESENCE OF THROMBUS. NO INTERVENTION WAS CARRIED OUT. NO ADVERSE EVENT WAS CAUSED TO THE PATIENT AS A RESULT.

  Patient problems: Thrombus

  MAUDE report 6188455 ↗
• MalfunctionDec 19, 2016Partial Blockage; Partial Blockage

  THE PHYSICIAN WAS ATTEMPTING TO USE A PROFLO DIAGNOSTIC CATHETER DURING A PROCEDURE. THE CATHETER WAS FLUSHED. IT IS REPORTED THAT CLOTS FORMED WITHIN THE CATHETER ONLY, WHEN THE PROFLO CATHETER WAS IN THE PATIENT. THE DEVICE WAS NOT FLUSHED DURING USE DUE TO THE PRESENCE OF THROMBUS. NO INTERVENTION WAS CARRIED OUT. NO ADVERSE EVENT WAS CAUSED TO THE PATIENT AS A RESULT.

  Patient problems: Thrombus

  MAUDE report 6184830 ↗