POWERFLEX 4401206XRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032072806), received between Dec 23, 2017 and Jun 17, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2024Leak/Splash; Leak/Splash

  AS REPORTED, A 12MM 6CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON LEAKED DURING USE. IT WAS ALSO NOTED THAT THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE CASE WAS COMPLETED WITH A NEW CORDIS 12X60 BALLOON. 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, 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 AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION. THE VESSEL WAS NOTED TO HAVE MODERATE TORTUOSITY. THE LESION HAD A 50% 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. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON THROUGH THE UNKNOWN GUIDE CATHETER. THE CATHETER WAS NEVER IN AN ACUTE BEND AND WAS NEVER KINKED DURING USE. THE SALINE/CONTRAST RATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19552863 ↗
• MalfunctionApr 24, 2024Material Frayed; Structural Problem; Material Split, Cut or Torn; Material Frayed; Structural Problem; Material Split, Cut or Torn

  AS REPORTED, THE 12MM 6CM POWERFLEX BALLOON WAS PUMPED TO THE RATED BURST PRESSURE BUT COULD NOT FILL PROPERLY, AND CONTINUED TO INCREASE THE PRESSURE AND STILL COULD NOT FILL. THE BALLOON WAS CHANGED TO A NON-CORDIS BALLOON, WITH THE SAME PRESSURE PUMP. THE BALLOON COULD FILL NORMALLY. IT WAS SUSPECTED THAT THE BALLOON WAS DAMAGED, OR THE FILLING CHAMBER WAS BLOCKED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS OCCURRED DURING AN ILIAC VEIN COMPRESSION SURGERY. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. THE PRODUCT EVALUATION SHOWED THE BALLOON WAS FRAYED/SPLIT AND MARKERBAND-OUT OF POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175821 ↗
• MalfunctionOct 11, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE POWERFLEX PRO 12MM 6CM BALLOON RUPTURED AT 18ATM WHICH WAS WITHIN THE RANGE OF BURSTING PRESSURE. THE BALLOON RUPTURED WHILE IN THE VESSEL; HOWEVER, IT DID NOT RUPTURE WHILE IN A PREVIOUSLY PLACED STENT. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE CASE WAS COMPLETED WITH THE USE OF A NEW UNKNOWN 12X60MM BALLOON CATHETER. THERE WAS REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED DURING INSERTION OF THE DEVICE THROUGH THE ROTATING HEMOSTATIC VALVE OR THROUGH THE GUIDE CATHETER. THE DEVICE WAS ABLE TO TRACK TOWARD THE LESION AND CROSS THE LESION WITHOUT DIFFICULTY. THE LESION WAS IN THE LEFT LOWER EXTREMITY ILIAC VEIN. THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION AND THE VESSEL HAD LITTLE TORTUOSITY. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576735 ↗
• MalfunctionApr 13, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A POWERFLEX PRO 12MM 6CM 135 BURST BEFORE REACHING THE RATED BURSTING PRESSURE, BELOW THE RBP. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT (IN ONE PIECE). THE CASE WAS COMPLETED WITH A NON-CORDIS BALLOON. 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 DEVICE FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR ANY OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS PREPPER NORMALLY. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE BALLOON RUPTURED WHILE IN THE SUPERFICIAL FEMORAL ARTERY. THE BALLOON WAS NOT IN A STENT WHEN IT RUPTURED. THE LESION WAS NOTED TO HAVE PLAQUE AND STENOSIS. THE LESION HAD MODERATE CALCIFICATION WITH A 55% STENOSIS. THE DEVICE WAS BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE MANUAL PRESSURE PUMP WAS FILLED WITH A SALINE/CONTRAST RATIO OF 1:1. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES DURING THE CASE. THERE WAS NO RESISTANCE/FR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107150 ↗
• MalfunctionFeb 3, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE PHYSICIAN WHEN TO INFLATE THE BALLOON OF A 12MM X 6CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER; HOWEVER, IT WAS UNABLE TO INFLATE. THE BALLOON DID NOT INFLATE. IN ADDITION, IT WAS NOTED THAT THE DEVICE WAS USED BEYOND EXPIRATION DATE. THERE WAS NO REPORTED PATIENT INJURY. PRODUCT ANALYSIS RESULTS REVEALED A BALLOON LEAKAGE DUE TO A RUPTURE OBSERVED AT THE BALLOON PROXIMAL SECTION OF THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274789 ↗
• MalfunctionAug 20, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHEN THE BALLOON OF A 12MM X 6CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DILATES, IT RUPTURED EVEN THE PRESSURE DOES NOT REACH THE RATED BURST PRESSURE (RBP). THERE WAS NO REPORTED PATIENT INJURY. ANOTHER UNKNOWN BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE TARGET LESION IS THE ILIAC VEIN WHICH WAS MODERATELY TORTUOUS AND EIGHTY PERCENT STENOSED. THE BALLOON WAS PREPPED, HANDLED AND STORED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO DIFFICULTY REMOVING THE PRODUCTS FROM THE HOOP, THE PROTECTIVE BALLOON COVERS, 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. A COMPETITOR'S CONTRAST MEDIA WAS USED WITH A ONE TO ONE RATION. A COMPETITOR'S INDEFLATOR DEVICE WAS USED WHICH WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WERE NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10433977 ↗
• MalfunctionJul 9, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF 12MM X 6CM 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FOUND LEAKING AND CANNOT BE FILLED WITH PRESSURE WHEN IT WAS BEING PRESSURIZED USING A PRESSURE PUMP. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET VESSEL WAS THE ILIAC VEIN. THE LESION WAS NOT CALCIFIED OR TORTUOUS. THE PERCENTAGE OF STENOSIS WAS 80%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR 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 DEVICE DID NOT PREP NORMALLY. THE CONTRAST TO SALINE RATION WAS 1:1 AND A NON CORDIS INFLATION DEVICE WAS USED. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE PLUNGER DEPRESSED INTO THE SYR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10250181 ↗
• MalfunctionJun 5, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE POWERFLEX PRO BALLOON CATHETER TRANSFER ROD CONNECTOR LEAKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7570986 ↗
• MalfunctionDec 23, 2017Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE POWERFLEX PRO 12MM 6CM 135 RUPTURED IN A CALCIFIED COMMON ILLIAC VESSEL. THERE WERE NO PATIENT INJURY. THE BALLOON INFLATE NORMALLY. THERE WAS NO DIFFICULTY INFLATING THE BALLOON DURING PREP. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, 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. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER, OR ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THE CATHETER EVER IN AN ACUTE BEND. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE TYPE AND BRAND OF INFLATION DEVICE WAS INDEFLATOR WHICH WAS SUCCESSFULLY USED WITH OTHER DEVICES. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7145228 ↗