POWERFLEX 4400702XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032059678), received between Apr 17, 2017 and Aug 12, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 7MM X 2CM X 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER POPPED WHILE INFLATED WITHIN THE INFLATION LIMITS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN STERILE FILED. THE DEVICE WAS PROPERLY STORED IN A TEMPERATURE-CONTROLLED ROOM, FOR ALMOST A YEAR. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE PROCEDURE USED VISIPAQUE 320 AT A 50:50 CONTRAST TO SALINE RATIO. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE BALLOON CATHETER WAS REMOVED EASILY AND INTACT. THE LESION HAD SEVERE CALCIFICATION. THERE WAS LITTLE TORTUOSITY, WITH 50% OR GREATER STENOSIS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED BY THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12311325 ↗
• MalfunctionJun 10, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 7MMX2CM 135¿ POWERFLEX PRO BALLOON RUPTURED DURING POST DILATION, FOLLOWING A STENT IMPLANTATION. IT IS NOTED THAT THE POWERFLEX PRO MIGHT HAVE GOTTEN CAUGHT ON THE STENT. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY, WITH OCCLUSION. A RIGHT FEMORAL APPROACH WAS MADE. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED DUE TO THE PATIENT HAVING A SUSPICIOUS INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682331 ↗
• MalfunctionApr 17, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A POWER FLEX PRO BALLOON CATHETER RUPTURED. THE DEVICE WAS REPLACED WITH A NEW POWER FLEX PRO AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. A NON-CORDIS 6F SHEATH INTRODUCER WAS INSERTED AND A NON CORDIS 0.35 GUIDEWIRE CROSSED THE LESION. A 7*8 SMART STENT WAS DEPLOYED IN THE LESION AND A POWER FLEX PRO WAS DELIVERED TO THE LESION FOR A POST-DILATATION. HOWEVER IT RUPTURED AT 8 ATM. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. THE DEVICE PREP NORMALLY AND ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE DEVICE PACKAGING. 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. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6496972 ↗