POWERFLEX 4400902SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032059890), received between Aug 24, 2017 and Aug 15, 2019 — classified as 2 malfunctions.

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

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.

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

  DURING USE, THE POWERFLEX PRO BALLOON CATHETER RUPTURE AT EIGHT ATMOSPHERE (8 ATM). THERE WAS NO PATIENT INJURY. THE POWERFLEX PRO WAS REMOVED AND A NEW COMPETITOR'S BC WAS USED TO COMPLETE THE PROCEDURE. THE TARGET LESION WAS THE LEFT COMMON ILIAC ARTERY WHICH HAS SEVERE CALCIFICATION AND HIGH RATE STENOSIS. AN IPSILATERAL APPROACH WAS MADE WITH A 6F COMPETITOR'S GUIDING SHEATH. A COMPETITOR'S GUIDEWIRE WAS INSERTED AND CROSSED THE LESION AND IVUS WAS USED TO CHECKED THE LESION. A POWERFLEX PRO BC WAS INSERTED AND AN ATTEMPTED WAS MADE TO INFLATED AT 8 ATM. HOWEVER IT RUPTURED DURING ITS INITIAL INFLATION. THEREFORE BALLOON WAS REPLACED WITH A NEW COMPETITOR'S BALLOON CATHETER AND IT INFLATED. AFTER THAT A NEW POWERFLEX PRO INFLATED AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8896321 ↗
• MalfunctionAug 24, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE POWER FLEX PRO BALLOON CATHETER WAS DELIVERED AND INFLATE HOWEVER, IT RUPTURED AT APPROXIMATELY 5 ATM. THEREFORE IT WAS REPLACED WITH A BALLOON CATHETER AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE ILIAC VEIN. 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 PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6818686 ↗