POWERFLEX 4400615XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032059623), received between Jun 5, 2017 and Mar 13, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 15CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT WORKING PRESSURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896979 ↗
• MalfunctionDec 9, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED, THE PHYSICIAN WAS NOT ABLE TO REINSERT THE POWERFLEX PRO 6MM 15CM BALLOON THROUGH A 6F 55CM NON-CORDIS SHEATH BECAUSE THE BALLOON WOULD NOT REWRAP. PHYSICIAN HAD PREVIOUSLY USED THE BALLOON FOR ONE INFLATION AND STRUGGLED TO REMOVE THE BALLOON THROUGH THE SHEATH. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE CASE WAS COMPLETED WITH A NEW UNKNOWN BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AT PROPER ROOM TEMPERATURE ON A CART. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, 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 WAS PREPPED PER THE IFU AND WAS PREPPED NORMALLY. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INTENDED LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION. THE VESSEL DID NOT HAVE ANY TORTUOSITY. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO DIFFICULTY ADVANCING THE BALLOON THROUGH THE VESSEL AND THE BAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951895 ↗
• MalfunctionJul 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, RADIOGRAPHIC AGENT WAS FOUND TO BE EXTRAVASATED DURING DILATION WITH THE POWERFLEX PRO 6MMX15CM. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PATIENT HAS A LONG SEGMENT STENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE UNKNOWN 5F SHEATH WAS PUNCTURED THROUGH THE RIGHT FEMORAL ARTERY. AFTER THE ANGIOGRAPHY WAS DONE, THAT SHEATH WAS REPLACED WITH A 6F 40CM NON-CORDIS SHEATH. A UNKNOWN GUIDE WIRE PASSED THROUGH THE LESION. THE NON-CORDIS BALLOON CATHETER WAS THAN EXPANDED AND THE NON-CORDIS STENT AND SMART STENT WERE PLACED. STENOSIS REMAINED AFTER ANGIOGRAPHY WAS DONE. THE POWERFLEX PRO 6X15 BALLOON WAS EXPANDED POSTERIORLY. THIS IS WHEN THE EXTRAVASATION WAS NOTED. A NEW POWERFLEX PRO 6X22 BALLOON WAS USED AND THE FLOW RATE OF CONTRAST WAS NORMAL. THE PRODUCT 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 KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION DID NOT HAVE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093373 ↗
• MalfunctionJul 13, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED, A POWERFLEX PRO 6MMX15CM 135 CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BECAME STUCK IN A 6F 10 CM RAIN SHEATH. THE SHEATH AND THE BALLOON HAD TO BE REMOVED AND A NEW UNKNOWN SHEATH WAS PLACED. THE BALLOON CATHETER WAS NOT EASILY REMOVED FROM THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON WAS PULLED ¿NEGATIVE¿ PRIOR AND DURING THE PROCESS OF TRYING TO REMOVE THE BALLOON FROM THE SHEATH. THE BALLOON WAS USED TO PERFORM A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERIES. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER OR REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. EIGHT ATM (ATMOSPHERES) WAS THE MAXIMUM INFLATION PRESSURE. THE BALLOON HAD MAINTAINED PRESSURE DURING INFLATION. THE BALLOON DEFLATED NORMALLY AND WAS COMPLETELY DEFLATED BEFORE TRYING TO REMOVE IT. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE PRODU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007965 ↗
• MalfunctionSep 9, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED, A 6MM X 15CM X 135CM POWER FLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT RE-ENTER THROUGH A 6F 55CM NON-CORDIS SHEATH USING A NON-CORDIS GUIDEWIRE. THE BALLOON APPEARED TO HAVE ¿WINGED¿ INSTEAD OF RE-WRAPPING. THE BALLOON WAS REMOVED WITH DIFFICULTY FROM THE SHEATH BUT WOULD NOT RE-ENTER ONCE REMOVED. A NEW POWERFLEX PRO 6X150 WAS PULLED FROM THE SHELF TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE USER WAS TRAINED WITH THE DEVICE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO DAMAGE NOTED TO THE PRODUCT UPON INSPECTION PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446854 ↗
• MalfunctionSep 25, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 135 6 MM X 15 CM POWERFLEX PRO BALLOON BURST IN THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9117863 ↗
• MalfunctionApr 27, 2019Partial Blockage; Partial Blockage

  DURING THE PERIPHERAL ANGIOPLASTY, THE POWERFLEX PRO PTA (6MM X 15CM 135CM) BALLOON CATHETER (BC) DID NOT PASS OVER THE GUIDEWIRE, THERE WAS MUCH RESISTANCE; THEREFORE, ANOTHER BALLOON WAS USED AND WORKED WELL. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE IFU. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WERE NO KINKS NOTED ON THE DEVICE PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED WITH HEPARINIZED SALINE. THE INSERTION DIFFICULTY WAS REPORTEDLY CAUSED BY A BLOCKAGE OF POSSIBLY INJECTABLE MATERIAL. THERE WAS NO EXCESSIVE FORCE APPLIED ON THE DEVICE WHILE ATTEMPTING TO INSERT IT OVER THE GUIDE WIRE. OTHER PRODUCTS WERE SUCCESSFULLY USED WITH THE DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. THE CATHETER WAS NOT TORQUED AGAINST RESISTANCE. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DIFFICULTY REQUIRE THAT ONLY THE REPORTED PRODUCT WAS REMOVED. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE PROCEDURE WAS COMPLETED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8559540 ↗
• MalfunctionJun 5, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT FIVE (5) POWERFLEX PRO BALLOON CATHETER (BC) BURST AT TEN TO TWELVE ATMOSPHERE (10-12 ATM) DURING THE INTERVENTION IN THE SAME PATIENT. THERE WAS NO PATIENT INJURY. THE DEVICE WAS PREP NORMALLY. THERE WERE NO DIFFICULTY INFLATING THE BALLOONS 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. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. CONTRAST MEDIA USED WAS SOLUTRAST 350. THE CONTRAST TO SALINE RATIO WAS CM+NACL. THE TYPE AND BRAND OF INFLATION DEVICE USED WAS ARCROYAL WHICH WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, GUIDE CATHETER, AND THROUGH THE VESSEL. THERE WERE NO DIFFICULTY CROSSING THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6610745 ↗