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POWERFLEX 4400710XRecalls & reported problems

Cordis Corporation · POWERFLEXPRO 7MM10CM 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 20705032059760), received between Sep 21, 2021 and Sep 21, 2021 — 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
  • 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.

  • MalfunctionSep 21, 2021Leak/Splash; Difficult to Remove; Leak/Splash; Difficult to Remove

    DURING AN INTERVENTIONAL PROCEDURE FOR LOWER EXTREMITY STENOSIS, A 7MM X 10CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS SENT TO THE LESION TO INCREASE THE PRESSURE PUMP; HOWEVER, IT WAS FOUND THAT PRESSURE COULD NOT RISE AND THE FRONT-END OF THE BALLOON HAS LEAKED. IT WAS REPLACED WITH A NEW BALLOON (UNKNOWN) TO COMPLETE THE OPERATION. THERE WAS ALSO RESISTANCE REMOVING THE DEVICE FROM THE RHV (ROTATING HEMOSTATIC VALVE). THERE WAS NO REPORTED PATIENT INJURY. THE 80% OCCLUDED LESION WAS NOT CALCIFIED AND THERE WAS NO VESSEL TORTUOSITY. THE DEVICE PREPPED NORMALLY. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. CONTRAST WAS AT A 1:1 RATIO. THE SAME INDEFLATOR WAS USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS N

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12507776 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

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