POWERFLEX 4400606XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032059548), received between Jan 17, 2019 and Oct 25, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionOct 25, 2021Deflation Problem; Deflation Problem

  DURING USE IN PATIENT, THE POWERFLEX PRO 6X6 CM X135 CM 5FR 0.035" BALLOON WOULD NOT DEFLATE COMPLETELY CAUSING DIFFICULTY OF THE BALLOON TO BE REMOVED FROM THE COMPETITOR'S SHEATH. THERE WAS NO PATIENT INJURY. THE PHYSICIAN REMOVED THE SHEATH WITH THE BALLOON INSIDE AND COMPLETED THE PROCEDURE. THE POWERFLEX PRO BALLOON WAS PREPPED PER THE INSTRUCTION FOR USE WITH NO ANOMALIES NOTED DURING PREP. THERE WERE NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED THROUGH THE BALLOON DURING INSERTION DURING PREP. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCTS INTO THE PATIENT. THE BALLOON WAS ABLE TO ENTERED THE 6 FR COMPETITOR'S SHEATH WELL, BUT THEN IT WAS NOT POSSIBLE TO REMOVE THE BALLOON FROM THE SHEATH AS THERE WAS A PROBLEM WITH DEFLATING THE BALLOON COMPLETELY. THE PHYSICIAN REMOVED BOTH THE SHEATH WITH THE BALLOON INSERTED FROM THE PATIENT AND ANOTHER COMPETITOR'S SHEATH WAS USED TO CONTINUE THE PROCEDURE. THE DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689740 ↗
• MalfunctionJan 17, 2019Material Integrity Problem; Material Integrity Problem

  THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THE 6MM6CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS TORN. ANALYSIS OF THE RETURNED DEVICE INDICATES BALLOON BURST. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256927 ↗