POWERFLEX 4150060SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032001561), received between Mar 10, 2022 and Mar 15, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K032737); they may or may not involve this specific model.

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.

• MalfunctionMar 15, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THREE POWERFLEX EXTREME BALLOONS WERE SENT; HOWEVER, TWO OF THREE LEAKED DURING POSITIVE PRESSURE WHILE INFLATING. THERE WAS NO REPORTED INJURY TO THE PATIENT AS THEY WERE NOT USED IN THE PATIENT. THE PRODUCT WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING THE STYLET/STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED PER THE IFU. IT WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. AN INDEFLATOR WAS USED WITH PURE WATER TO INFLATE THE BALLOON. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13772995 ↗
• MalfunctionMar 15, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THREE POWERFLEX EXTREME BALLOONS WERE SENT; HOWEVER, TWO OF THREE LEAKED DURING POSITIVE PRESSURE WHILE INFLATING. THERE WAS NO REPORTED INJURY TO THE PATIENT AS THEY WERE NOT USED IN THE PATIENT. THE PRODUCT WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING THE STYLET/STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED PER THE IFU. IT WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. AN INDEFLATOR WAS USED WITH PURE WATER TO INFLATE THE BALLOON. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13772829 ↗
• MalfunctionMar 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED, TWO POWERFLEX EXTREME 10X6 80CM BALLOON CATHETERS LEAKED BEFORE REACHING RATED BURST PRESSURE (RBP). THERE WAS NO PATIENT INJURY AS THESE BALLOON WERE TESTED FOR DEFLATION TIME. THE POWERFLEX EXTREME CURRENTLY IS IN CHINA REGISTRATION PROCESS. THE TEST METHOD IS TO INFLATE THE BALLOON TO RBP FIRST AND DEFLATE IT, AND THEN RECORD THE DEFLATION TIME AS THE TEST RESULT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY NOTED WHILE REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, INNER STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INFLATION DEVICE WAS FILLED WITH PURE WATER AND WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE POWERFLEX EXTREME BALLOON WAS NEVER ON AN ACUTE BEND. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13723665 ↗
• MalfunctionMar 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED, TWO POWERFLEX EXTREME 10X6 80CM BALLOON CATHETERS LEAKED BEFORE REACHING RATED BURST PRESSURE (RBP). THERE WAS NO PATIENT INJURY AS THESE BALLOON WERE TESTED FOR DEFLATION TIME. THE POWERFLEX EXTREME CURRENTLY IS IN CHINA REGISTRATION PROCESS. THE TEST METHOD IS TO INFLATE THE BALLOON TO RBP FIRST AND DEFLATE IT, AND THEN RECORD THE DEFLATION TIME AS THE TEST RESULT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY NOTED WHILE REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, INNER STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INFLATION DEVICE WAS FILLED WITH PURE WATER AND WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE POWERFLEX EXTREME BALLOON WAS NEVER ON AN ACUTE BEND. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13723004 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032737. One submission often covers many models, so check the product and lot details in each record.

• Z-1477-2020 · Jan 8, 2020 · Terminated
  Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S