POWERFLEX 4156040TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032001769), received between May 2, 2017 and Jan 15, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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.

• MalfunctionJan 15, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6X4 40CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INSERTED AND INFLATED. HOWEVER, IT RUPTURED AT 10 ATM DURING ITS INITIAL INFLATION. NO PATIENT INJURY WAS REPORTED. THIS WAS A VASCULAR ACCESS INTERVENTION THERAPY (VAIVT) CASE. THE LESION WAS CALCIFIED. THE PRODUCT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8247626 ↗
• MalfunctionMay 2, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE 6X40MM POWERFLEX EXTREME BALLOON CATHETER (BC) RUPTURED AT RATED BURST PRESSURE. THE BALLOON RUPTURED AT TWENTY ATMOSPHERES (20 ATM). IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. THE TARGET LESION WAS SUBCLAVIAN WHICH WASN'T TORTUOUS OR CALCIFIED. THE DEVICE PREPPED 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. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER, OR THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NOT IN AN ACUTE BEND. THE CONTRAST MEDIA USED WAS THE OMNIPAQUE 300 WITH A CONTRAST TO SALINE RATIO OF 50/50. BARD WAS THE INFLATION DEVICE USED WHICH WAS SUCCESSFULLY USED WITH OTHER DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6536979 ↗

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