POWERFLEX 4204040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032004081), received between Oct 23, 2017 and Jan 13, 2022 — 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 13, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A POWERFLEX 80 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT THIRD INFLATION WHEN INFLATED TO 15 ATM. THE BALLOON WAS REMOVED WITHOUT INCIDENT AND THE PROCEDURE WAS COMPLETED WITH A NON CORDIS BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET VESSEL WAS A JUXTANASTAMOSIS. THE LESION HAD 85% STENOSIS AND MODERATE CALCIFICATION. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. A 50/50 CONTRAST:SALINE MIX WAS USED. A NON CORDIS INDEFLATOR 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 NOR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252224 ↗
• MalfunctionOct 23, 2017Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER REPORTS A 4 X 40 MM POWERFLEX P3 PTA DILATATION CATHETER RUPTURED AFTER TAKING IT ONCE TO FOURTEEN (14) ATMOSPHERES (ATM) IN THE FISTULA ANASTAMOSIS. THE DEVICE WAS REMOVED WITHOUT INCIDENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY. THERE WERE NO DIFFICULTY INFLATING THE BALLOON DURING PREP. THE BALLOON INFLATE 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 CONTRAST MEDIA USED WAS GE OMNIPAQUE WITH A 50/50 CONTRAST TO SALINE RATIO. THE TYPE AND BRAND INFLATION DEVICE USED WAS MERIT BASIX WHICH WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6968629 ↗

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