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POWERFLEX 4400708XRecalls & reported problems

Cordis Corporation · POWERFLEXPRO 7MM8CM 135 · 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 20705032059746), received between Aug 8, 2023 and Aug 8, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

  • Burst Container or Vessel1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 8, 2023Burst Container or Vessel; Burst Container or Vessel

    AS REPORTED, A 7MM X 8CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED SUCCESSFULLY AND WAS REMOVED TO BE USED LATER IN THE PROCEDURE. HOWEVER, UPON FLUSHING THE BALLOON CATHETER PRIOR TO RE-USING IT, THE CATHETER SHAFT BURST. THE PROCEDURE WAS ENDED AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS OCCURRED DURING A PROCEDURE IN WHICH A LOWER LEG ARTERIOGRAM WAS PERFORMED. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THERE WERE NO DIFFICULTIES REMOVING THE STERILE PACKAGING COMPONENTS. THE INITIAL INFLATION OF THE BALLOON WAS BELOW THE RATED BURST PRESSURE (RBP). AFTER INITIAL USE OF THE DEVICE, THE DEVICE WAS COILED AND LAID FLAT ON THE SCRUB TABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17483347 ↗

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.