POWERFLEX 4204020TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032004036), received between Oct 5, 2017 and Oct 5, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• MalfunctionOct 5, 2017Burst Container or Vessel; Burst Container or Vessel

  IN A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE, IT WAS REPORTED THAT A POWER FLEX P3 BALLOON CATHETER WAS DELIVERED TO THE LESION AND INFLATED. HOWEVER IT RUPTURED AT FOUR (4) ATMOSPHERE (ATM). THEREFORE THE BALLOON CATHETER WAS REPLACED WITH A NEW POWER FLEX P3 AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TARGET LESION WAS THE SHUNT. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE DEVICE PREP NORMALLY. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, 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 PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE PRODUCTS WERE CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6917242 ↗

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