POWERFLEX 4400310XRecalls & reported problems
Cordis US Corp. · POWERFLEXPRO 3MM10CM 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 20705032059050), received between Dec 20, 2023 and Dec 20, 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.
Reports received per month
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.
MalfunctionDec 20, 2023Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THERE WAS DIFFICULTY ADVANCING AN UNKNOWN POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO THE LESION AND THE DEVICE WAS UNABLE TO CROSS THE LESION. AS A RESULT, 3MM X 100MM NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURED TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 70% STENOSED POPLITEAL ARTERY LESION WHICH HAD MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A BALLOON BURST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18366792 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.