POWERFLEX 4206040TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032004449), received between Aug 28, 2019 and Oct 5, 2020 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING A SHUNT CASE IN THE BRACHIAL VEIN, CONTRAST MEDIA LEAKED FROM THE DISTAL END OF A 6MM X 4MM X 40CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AFTER IT CROSSED THE LESION WHILE CONNECTED TO AN INDEFLATOR AND INFLATED. IT WAS REPLACED WITH ANOTHER SAME SIZED BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10626667 ↗
• MalfunctionAug 28, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWER FLEX P3 (F5 6X4 40) WAS INSERTED; HOWEVER, IT RUPTURED AT 4 ATMOSPHERES (ATM). THEREFORE, IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER OF THE SAME SIZE AND IT COULD BE INFLATED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS DISCARDED IN THE HOSPITAL. THIS WAS A VASCULAR ACCESS (VA) INTERVENTION THERAPY (VAIVT) CASE. THE LESION HAD CALCIFICATION. THE PRODUCT LOOKED NORMAL WHEN REMOVED FROM ITS PACKAGING. THE DEVICE PREPPED NORMALLY (I.E. MAINTAINED NEGATIVE PRESSURE). THERE WAS NO DIFFICULTY 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%. A NON-CORDIS 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. THE DEVICE DID NOT HAVE TO PASS THROUGH A PREVIOUSLY PLACED STENT. THE BALLOON INFLATED NORMALLY. THE BALLOON WAS INFLATED ONCE PRIOR TO THE BURST. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940590 ↗

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