POWERFLEX 4206080SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032004494), received between Jul 17, 2019 and Jul 17, 2019 — 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.

• MalfunctionJul 17, 2019Leak/Splash; Leak/Splash

  AS REPORTED, A 5F POWERFLEX P3 6X8 80 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) THE BALLOON WOULD NOT INFLATE IN THE PATIENT, AFTER REMOVAL FROM THE PATIENT AND THE WIRE, IT WAS FOUND THAT THERE WAS A PINHOLE AT THE TIP OF THE BALLOON BY USING A SYRINGE. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS COMPLETED USING A NON-CORDIS BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8799139 ↗

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