POWERFLEX 4400422XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032059272), received between Sep 21, 2020 and Apr 4, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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.

• MalfunctionApr 4, 2022Crack; Crack

  AS REPORTED, A 4MM X 22CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FOUND TO BE CRACKED DURING A BALLOON INFLATION TO 10 ATMOSPHERES (ATM). AS A RESULT, THE BALLOON WAS IMMEDIATELY DEFLATED AND THE DEVICE WAS REPLACED WITH ANOTHER 4MM X 22CM CORDIS BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 70% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) IN WHICH THE POWERFLEX PRO PTA BALLOON CATHETER WAS USED FOR PRE-DILATION OF THE LESION. THERE WAS NO CALCIFICATION OR TORTUOSITY TO THE TARGET VESSEL AND THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION AND AN UNKNOWN INFLATION DEVICE WAS PREPPED WITH BAYER CONTRAST AT A 1:1 CONTRAST TO SALINE RATIO. THE SAME, UNKNOWN INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES DURING THE PROCEDURE. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED AS THE BALLOON ENTERED THE PATIENT. THERE WAS NO DIFFICULTY ADVANCING THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13996566 ↗
• MalfunctionSep 21, 2020Leak/Splash; Leak/Splash

  DURING OPERATION PROCESS, WHEN USING A 4MM X 22CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS LEAKING AND CANNOT BE FILLED. THERE WAS NO REPORTED PATIENT INJURY. AFTER ANGIOGRAPHY, IT WAS FOUND THAT THE LIMB HAD OCCLUSIVE ARTERIOSCLEROSIS AND IMPLANTED AN UNKNOWN STENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10560467 ↗