POWERFLEX 4154040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032001615), received between Nov 12, 2021 and Nov 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

1 other recall cover devices cleared under the same FDA submission (K032737); they may or may not involve this specific model.

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

Recent adverse event reports

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

• MalfunctionNov 12, 2021Leak/Splash; Leak/Splash

  AS REPORTED, THE OPERATOR ATTEMPTED TO INFLATE A 4MM X 4MM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER; HOWEVER, S/HE NOTICED A LEAK AND THE BALLOON WOULD NOT INFLATE. THEREFORE, IT WAS REMOVED AND DISCARDED, AND AN ADDITIONAL PRODUCT (UNKNOWN) WAS OPENED AND USED TO FINISH THE CASE. THE POWERFLEX WAS OPENED ON THE STERILE TABLE AS PER INSTRUCTIONS FOR USE (IFU). IT WAS INSERTED OVER AN UNKNOWN WIRE. THE INTENDED PROCEDURE WAS A FISTULAGRAM. LEAKAGE WAS NOTED FROM THE BALLOON. A .035 UNKNOWN GUIDEWIRE WAS USED. THE LESION WAS NOT CALCIFIED OR TORTUOUS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS DIFFICULTY NO REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE CONTRAST TO SALINE RATIO WAS 50/50. A SYRINGE INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO DIFFICULTY ADVANCING TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12803340 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032737. One submission often covers many models, so check the product and lot details in each record.

• Z-1477-2020 · Jan 8, 2020 · Terminated
  Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S