Skip to content

POWERFLEX 4400710SRecalls & reported problems

Cordis Corporation · POWERFLEXPRO 7MM10CM 80 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032059753), received between Mar 19, 2019 and Mar 19, 2019 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • Leak/Splash1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 19, 2019Leak/Splash; Leak/Splash

    AS REPORTED, A POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS PUT INTO THE PATIENT, BUT THE BALLOON WOULD NOT REACH THE DESIRED PRESSURE AFTER TWO ATTEMPTS DUE TO A SMALL HOLE AT THE REAR END OF THE BALLOON THAT WAS NOTICED WHEN IT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY. THE POWERFLEX PRO PTA BC WAS FLUSHED BEFORE USE. A NEW POWERFLEX PTA BC WAS USED TO COMPLETE THE PROCEDURE. THE LESION HAD MODERATE CALCIFICATION. THE PATIENT IS HEALTHY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8432361 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

All Catheter, angioplasty, peripheral, transluminal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.