POWERFLEX 4150040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032001547), received between May 11, 2020 and May 11, 2020 — 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.

• MalfunctionMay 11, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE 5MM X 4MM 80CM AND 10MM X 4MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS COULD NOT INFLATE UPON INITIAL USE. THE DOCTOR WOULD INFLATE THE BALLOON AND THE BALLOON WOULD NOT RETAIN PRESSURE BECAUSE IT WOULD LEAK FROM THE TIP. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS ANGIOPLASTY IN THE OUTFLOW STENT AT THE SUBCLAVIAN VEIN. THE LESION WAS NOT CALCIFIED, HAD NO VESSEL TORTUOSITY, HAD STENOSIS OF 50% AT OUTFLOW STENT AND 90% AT SUBCLAVIAN VEIN. THE DEVICES WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE PRODUCTS WERE STORED AS PER LABELING AND WERE OPENED IN STERILE FIELD. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICES WERE NOT PREPPED NORMALLY AS LEAKAGE WAS NOTED AT THE TIP OF THE BALLOON. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. A NON-CORDIS CONTRAST WAS USED. THE CONTRAST TO SALINE RATIO WAS 50/50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO R

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10044230 ↗

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