POWERFLEX 4401004XRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032060063), received between May 14, 2019 and Mar 18, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED, A 10MM 4CM POWERFLEX PRO PTA BURST IN AN ILIAC ARTERY, AND IT GOT STUCK IN THE 6F CORDIS BRITE TIP RADIANZ. THE BALLOON WAS NOTED TO HAVE BURST/ RUPTURED AT 6ATM. A NEW BRITE TIP RADIANZ WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT 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 DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. A 6F CORDIS BRITE TIP SHEATH WAS USED DURING THE PROCEDURE. THE LESION WAS NOTED TO HAVE SEVERE CALCIFICATION WITH LITTLE VESSEL TORTUOSITY. THE LESION WAS NOTED TO HAVE AN 85% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE UNKNOWN GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON THROUGH THE VESSEL. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924306 ↗
• MalfunctionFeb 9, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, IT WAS NOT POSSIBLE TO RETRACT THE 10 MM X 4CM X 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER THROUGH A NON-CORDIS SHEATH AFTER SUCCESSFUL INTERVENTION OF SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION. THE SHEATH WAS REMOVED TOGETHER WITH THE POWERFLEX, AND MANUAL COMPRESSION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY; MAINTAINED NEGATIVE PRESSURE. THERE WAS NEITHER RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER NOR DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE BALLOON WAS DEFLATED SEVERAL TIMES TO GET IT THROUGH THE SHEATH. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16340425 ↗
• MalfunctionApr 20, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 10MM X 4CM X 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DID NOT INFLATE WHEN THE PHYSICIAN WENT TO INFLATE IT. THERE WAS NO REPORTED PATIENT INJURY AND THE DEVICE WAS RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A RUPTURE TO THE MID PORTION OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160587 ↗
• MalfunctionDec 20, 2021Leak/Splash; Leak/Splash

  DURING USE OF THE POWERFLEX PRO BALLOON CATHETER, WHEN THE PRESSURE PUMP WAS USED TO INFLATE THE BALLOON, THE PRESSURE COULD NOT REACH FIVE ATMOSPHERE (5 ATM). WHEN THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY, IT WAS FOUND THAT THE BALLOON LEAKED AT MANY PLACES. THERE IS NO PATIENT INJURY. THE POWERFLEX PRO WAS REPLACED WITH ANOTHER POWERFLEX PRO TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS AN ARTERIAL THROMBOSIS OF THE LOWER EXTREMITY WHICH WAS NOT OCCLUDED IN THE PREVIOUS THREE MONTHS. THE POWERFLEX PRO WAS PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO ANOMALIES NOTED. THE SAME INFLATOR DEVICE USED WAS SUCCESSFULLY USED WITH OTHER DEVICES. WHEN THE PRESSURE PUMP WAS USED TO INFLATE THE BALLOON, THE PRESSURE COULD NOT REACH 5 ATM. WHEN THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY, IT WAS FOUND THAT THE BALLOON LEAKED AT MANY PLACES. THE DEVICE WAS REPLACED WITH ANOTHER POWERFLEX PRO TO COMPLETE THE PROCEDURE. THE DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044280 ↗
• MalfunctionFeb 23, 2021Material Rupture; Material Rupture

  DURING AN INTERVENTIONAL PROCEDURE IN THE ILIAC ARTERY, A 10MM X 4CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER IT RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY MISTAKE. THE ACCESS SITE WAS THE FEMORAL ARTERY. THERE WAS NO DIFFICULTY REMOVING THE FORMING TUBE OFF THE BALLOON. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON CATHETER WAS REMOVED EASILY FROM THE VESSEL AND FROM THE OTHER DEVICES. ADDITIONAL PATIENT AND PROCEDURAL DETAILS WERE REQUESTED BUT ARE NOT AVAILABLE BECAUSE THE SALES REP CANNOT VISIT THE FACILITY DUE TO COVID-19.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365271 ↗
• MalfunctionJul 31, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 10MM X 4CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER HAD RUPTURED DURING USED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS AT THE ILIAC ARTERY WITH CALCIFICATION. THE LESION WAS SEVERELY CALCIFIED. THE VESSEL TORTUOSITY WAS SEVERE. THE PERCENTAGE OF STENOSIS WAS 80%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS DIFFICULTY CROSSING THE LESION. THE CATHETER WAS IN AN ACUTE BEND. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND WHEN 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 PREPPED NORMALLY. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THROUGH THE GUIDE CATHETER. THE USER WAS UNABLE TO DEPRESS THE PLUNGER INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. THE BALLOON INFL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10351982 ↗
• MalfunctionMay 14, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO BALLOON CATHETER (10MM4CM 135) WAS DELIVERED TO THE LESION IN THE LEFT SUBCLAVIAN VEIN AND INFLATED, HOWEVER, THE DEVICE RUPTURED AT 6 ATMOSPHERES (ATMS) DURING ITS SECOND INFLATION. THE DEVICE WAS REPLACED WITH A NON-CORDIS BALLOON CATHETER OF THE SAME SIZE TO COMPLETE THE PROCEDURE. INITIALLY, AN APPROACH WAS MADE FROM THE FEMORAL ARTERY USING A NON-CORDIS GUIDING SHEATH, A NON-CORDIS GUIDEWIRE CROSSED THE LESION AND A NON-CORIDS BALLOON CATHETER WAS USED FOR INITIAL DILATION. THE KESION WAS DESCRIBED AS HAVING REPEATED SEVERE STENOSIS. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED AND HAS BEEN DISCARDED, SO WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8609312 ↗