POWERFLEX 4400308XRecalls & reported problems
Cordis US Corp. · POWERFLEXPRO 3MM8CM 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 20705032059036), received between Jan 20, 2023 and Jan 20, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
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.
MalfunctionJan 20, 2023Difficult to Remove; Difficult to Remove
AS REPORTED THE BALLOON ON A POWERFLEX PRO 3MM X 8CM 135CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATION CATHETER COULD NOT BE INFLATED. THE BALLOON CATHETER WAS NOT EASILY REMOVED BUT IT WAS WITHDRAWN FROM THE BODY AND REPLACED WITH ANOTHER UNKNOWN NON-CORDIS PRODUCT. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. CONTRAST TO SALINE RATIO WAS ONE TO ONE. THE UNKNOWN INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. WHILE INFLATING THE DEVICE WITH P
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16214887 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.