POWERFLEX 4400408XRecalls & reported problems
Cordis US Corp. · POWERFLEXPRO 4MM8CM 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 20705032059197), received between Apr 7, 2024 and Apr 7, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
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.
MalfunctionApr 7, 2024Leak/Splash; Leak/Splash
AS REPORTED, THE BALLOON OF A 4MM8CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER WAS FOUND TO HAVE A HOLE WHEN BEING INFLATED. THE BALLOON WAS CAUGHT IN THE LESION, AND ABLE TO BE REMOVED INTACT EASILY FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE HOLE WAS FOUND JUST AS THE DEVICE WAS INFLATED. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION FOR 4 SECONDS. THE DEVICE WAS INFLATED TO 8 ATMOSPHERES BEFORE THE ANOMALY WAS NOTED. THERE WERE NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE GAUGE OF THE INDEFLATOR INDICATED A LOSS OF PRESSURE WHEN THE ANOMALY WAS NOTED. A CONTRALATERAL APPROACH WAS USED. THE TARGET VESSEL WAS THE SUPERFICIAL FEMORAL ARTERY. THE TARGET VESSEL SITE HAD MILD CALCIFICATION AND TORTUOSITY. THERE WAS 35% STENOSIS AND THERE WAS NO ACUTE ANGLE OR BIFURCATION. THE DEVICE WAS NO PUT INTO AN ACUTE BEND AT ANY POINT DURING THE PROCEDURE. THE DEVICE WAS ABLE TO CROSS THE LESION. THE DEVICE DID NOT KINK AT ANY TIME DURIN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19056912 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.