POWERFLEX 4158060SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032001974), received between Nov 7, 2019 and Mar 9, 2023 — classified as 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2023Leak/Splash; Leak/Splash

  AS REPORTED, THERE WAS A LEAK UPON INFLATION OF A POWERFLEX EXTREME 8MM X 6CM 80CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518585 ↗
• MalfunctionNov 15, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF AN 8X6 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER LEAKED CONTRAST AT THE PROXIMAL SIDE OF THE BALLOON WHEN INFLATED AT FIVE ATMOSPHERES (ATM) PRESSURE. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT (IN ONE PIECE). ANOTHER SAME SIZE CORDIS BALLOON WAS USED AND WORKED WELL. THE CASE WAS COMPLETED. THERE IS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED PER LABELING. THE USER IS TRAINED IN THE DEVICE. THE DEVICE WAS USED FOR A FISTULAGRAM. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, 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 AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. A NON-CORDIS INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15802414 ↗
• MalfunctionFeb 19, 2021Leak/Splash; Leak/Splash

  DURING AN INTERVENTIONAL PROCEDURE AN 8MM X 6CM X 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT INFLATE PAST 6 ATMOSPHERES (ATM) AND THEY ASSUMED BALLOON RUPTURE BECAUSE SALINE/CONTRAST MIX WAS COMING OUT THE WIRE HOLE AT THE FRONT OF THE BALLOON. THEREFORE, THE BALLOON WAS REMOVED, AND THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT WAS FINE AND THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR WAS TRAINED TO THE POWERFLEX DEVICE. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION. A FISTULAGRAM IN A VEIN IN THE UPPER ARM (NO MORE SPECIFICS) WAS BEING PERFORMED. THERE WAS NO CALCIFICATION OR VESSEL TORTUOSITY. THERE WAS 50-60% STENOSIS. THERE WAS NO DIFFICULTY REMOVING THE BALLOON FROM THE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE CONTRAST MEDIA WAS OMNIPAQUE GE 300. THE CONTRAST TO SALINE RATIO WAS 5CC CONTRAST ADDED TO 10CC SALINE. THE TYPE AND BRAND OF INFLATION DEVICE WAS BAXIX COMPAK. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348367 ↗
• MalfunctionDec 17, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN 8MMX6MM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) HAD A CONTRAST LEAKED FROM THE TOP WHEN USING INSIDE THE PATIENT. THEREFORE, THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER CORDIS DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE INTENDED PROCEDURE/TARGET LESION WAS FISTULA. THE LESION WAS NOT CALCIFIED AND THERE WAS NO VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). 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 THE PRODUCT INTO THE PATIENT. THE MAXIMUM INFLATION PRESSURE WAS NOMINAL. THE BALLOON DID NOT S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9484809 ↗
• MalfunctionNov 7, 2019Leak/Splash; Leak/Splash

  AS REPORTED, WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE 8X6 80CM POWERFLEX EXTREME BALLOON CATHETER (BC), IT DIDN¿T FULLY INFLATE DURING INITIAL INFLATION AS THE CONTRAST JUST KEPT COMING OUT. IT HAPPENED INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS COMPLETED USING ANOTHER CORDIS BALLOON. THEREFORE, THE POWERFLEX BALLOON CATHETER WAS REMOVED FROM THE PATIENT, INSPECTED AND TOSSED. THE DEVICE WAS STORED AS PER THE LABELING. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE LEAKAGE SAW UNDER FLUOROSCOPY. THE LEAKAGE WAS FROM THE BALLOON. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291721 ↗

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