POWERFLEX 4400602SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032059463), received between Jan 15, 2020 and Sep 1, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 20MM 80CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED PRIOR TO REACHING ITS NOMINAL PRESSURE DURING A PRE-DILATION INFLATION. AS A RESULT, AN UNKNOWN BALLOON CATHETER WAS USED TO CONTINUE THE PROCEDURE AND A NON-CORDIS STENT WAS IMPLANTED. THE UNKNOWN BALLOON CATHETER WAS USED FOR POST-DILATION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN INTERVENTIONAL PROCEDURE TO TREAT A LESION IN THE ILIAC ARTERY. AN IPSILATERAL RETROGRADE APPROACH WAS USED FOR THIS PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE DEVICE HAS NOW BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669580 ↗
• MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, THE FACILITY RECEIVED 10 POWERFLEX PRO BALLOONS (MULTIPLE SIZES) THAT WERE CONTAMINATED WITH DIRT PARTICLES EITHER IN BOX AND OR PACKAGING. FOR FEAR OF CONTAMINATING STERILE FIELD, TWO OF THESE BALLOONS THAT WERE GOING TO BE USED DID NOT GET OPENED BECAUSE PROCEDURAL PERSON NOTICED THE DIRT PRIOR TO OPENING. UPON FURTHER INSPECTION OF REMAINING BALLOONS, THEY DISCOVERED THAT AN ADDITIONAL 8 BALLOONS WERE SIMILARLY CONTAMINATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT IS UNKNOWN IF THE DIRT PARTICLES WERE WITHIN THE SEALED PORTION OF THE PACKAGES. THE FACILITY DOES NOT HAVE A RECEIVING BAY. THE DEVICES WERE STORED FOR APPROXIMATELY ONE MONTH PRIOR TO USE. THERE WERE NO DAMAGES NOTED TO THE SHIPPING BOXES. THERE WAS NO DAMAGE NOTED TO THE ACTUAL DEVICE PACKAGING. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17635067 ↗
• MalfunctionFeb 27, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING POST DILATION THE BALLOON OF 6MM X 2CM 80 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 15 ATMOSPHERES (ATM) RATED BURST PRESSURE (RBP) AFTER THE STENT WAS BEING IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY. INITIALLY, THE POWERFLEX PRO WAS USED FOR PRE DILATION AND INFLATED AT 8 ATM AT THE FIRST INFLATION AND 15 ATM DURING THE SECOND INFLATION. THE LESION WAS AT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND THE APPROACH WAS MADE FROM THE LEFT COMMON FEMORAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED DUE TO SUSPICION FOR INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765219 ↗
• MalfunctionJan 15, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 20MM X 80CMPOWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED WITHIN ITS NOMINAL PRESSURE DURING ITS INITIAL INFLATION. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE ILIAC ARTERY. THE LESION HAD SEVERE CALCIFICATION. THERE WAS MILD VESSEL TORTUOSITY WITH NINETY PERCENT (90%) STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). INITIALLY, THIS WAS AN ENDOVASCULAR THERAPY (EVT) CASE. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY. A NON-CORDIS CONTRAST MEDIA WAS USED IN THE PROC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592685 ↗