POWERFLEX 4202040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032003961), received between Apr 11, 2022 and Oct 14, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF THE POWERFLEX P3 F5 12X4 RUPTURED DURING THE A DIALYSIS FISTULAGRAM. THE MATERIAL WAS NOTED TO HAVE BROKE IN HALF WHEN TRYING TO REMOVE FROM THE PATIENT. AFTER THE PROCEDURE WAS COMPLETED, THE DEVICE WAS INSPECTED AND IT WAS DETERMINED NO REMNANTS WERE LEFT BEHIND. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE DEVICE WAS REMOVED OVER THE WIRE FROM THE PATIENT ALONG WITH THE SHEATH. A NEW SHEATH WAS INSERTED AND THE PROCEDURE PROCEEDED AS NORMAL WITH ADDITIONAL ANGIOPLASTY. THE POWERFLEX WAS INFLATED IN A NARROWED VEIN IN ATTEMPT TO IMPROVE FLOW FOR FUTURE DIALYSIS TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. AN IMAGE OF THE DEVICE WAS PROVIDED. THE IMAGE APPEARS TO BE A USED BALLOON CATHETER WITH BLOOD RESIDUES. PRODUCT SPECIFICS ARE NOT PROVIDED IN THE IMAGE. THE BALLOON IS RUPTURED AND SEPARATED. AN INTACT MARKER BAND IS VISIBLE ON THE BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607442 ↗
• MalfunctionSep 17, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER THE SUCCESSFUL INITIAL INFLATION OF A 12MM X 4CM 80CM POWERFLEX P3 F5 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON RUPTURED DURING SUBSEQUENT INFLATIONS. A SECOND 12MM X 4CM 80CM POWERFLEX P3 F5 PTA BALLOON CATHETER WAS THEN USED IN PLACE OF THE RUPTURED POWERFLEX P3 F5 PTA BALLOON CATHETER; HOWEVER, THE BALLOON OF THE SECOND POWERFLEX P3 F5 PTA BALLOON CATHETER RUPTURED DURING ITS INITIAL INFLATION. A 9MM X 4CM 80CM POWERFLEX P3 F5 PTA BALLOON CATHETER WAS USED TO REPLACE THE SECOND POWERFLEX P3 F5 PTA BALLOON CATHETER; HOWEVER, THE 9MM X 4CM POWERFLEX P3 F5 PTA BALLOON CATHETER APPEARED TO LEAK CONTRAST INTO THE VESSEL. UPON REMOVAL OF THE THIRD POWERFLEX P3 F5 PTA BALLOON CATHETER, BLOOD WAS OBSERVED ON THE INSIDE OF THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A FISTULA LESION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443125 ↗
• MalfunctionSep 17, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER THE SUCCESSFUL INITIAL INFLATION OF A 12MM X 4CM 80CM POWERFLEX P3 F5 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON RUPTURED DURING SUBSEQUENT INFLATIONS. A SECOND 12MM X 4CM 80CM POWERFLEX P3 F5 PTA BALLOON CATHETER WAS THEN USED IN PLACE OF THE RUPTURED POWERFLEX P3 F5 PTA BALLOON CATHETER; HOWEVER, THE BALLOON OF THE SECOND POWERFLEX P3 F5 PTA BALLOON CATHETER RUPTURED DURING ITS INITIAL INFLATION. A 9MM X 4CM 80CM POWERFLEX P3 F5 PTA BALLOON CATHETER WAS USED TO REPLACE THE SECOND POWERFLEX P3 F5 PTA BALLOON CATHETER; HOWEVER, THE 9MM X 4CM POWERFLEX P3 F5 PTA BALLOON CATHETER APPEARED TO LEAK CONTRAST INTO THE VESSEL. UPON REMOVAL OF THE THIRD POWERFLEX P3 F5 PTA BALLOON CATHETER, BLOOD WAS OBSERVED ON THE INSIDE OF THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A FISTULA LESION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443113 ↗
• MalfunctionApr 29, 2022Leak/Splash; Leak/Splash

  AS REPORTED, DURING INFLATION OF A 6MM X 4CM 80CM POWERFLEX EXTREME PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WITH A SYRINGE, THE BALLOON WAS MINIMALLY INFLATED, AND A LEAKAGE OF CONTRAST WAS OBSERVED COMING FROM THE BALLOON. AS A RESULT, THE 6MM X 4CM 80CM POWERFLEX EXTREME PTA BALLOON CATHETER WAS REMOVED, AND AN UNKNOWN BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE 6MM X 4CM 80CM POWERFLEX EXTREME PTA BALLOON CATHETER WAS PREPPED IN THE STERILE FIELD PER THE INSTRUCTIONS FOR USE (IFU). A 50/50 CONTRAST AND SALINE MIXTURE WAS USED TO PREP THE BALLOON OF THE 6MM X 4CM 80CM POWERFLEX EXTREME AND THE DEVICE 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 AS THE DEVICE WAS BEING INSERTED. THE POWERFLEX EXTREME WAS ADVANCED OVER UNKNOWN GUIDEWIRE TO TREAT THE LESION AND WAS ABLE TO TRACK TOWARD THE LESION AND CROSS WITHO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14249948 ↗
• MalfunctionApr 12, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THERE WAS A LEAK AT THE DISTAL BALLOON TIP OF A 12MM X 4CM 80CM POWERFLEX P3 .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. AS A RESULT, A NEW 12MM X 4CM 80CM POWERFLEX P3 PTA BALLOON CATHETER WAS SUCCESSFULLY USED IN PLACE OF THE LEAKING 12MM X 4CM 80CM POWERFLEX PTA BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT AND THE PATIENT HAS BEEN DISCHARGED. THIS WAS DURING A PROCEDURE TO TREAT A CALCIFIED RIGHT UPPER ARM FISTULA IN THE RIGHT BRACHIOCEPHALIC VEIN WHICH HAD A CENTRAL STENOSIS OF 80% AND AN OUTFLOW STENOSIS OF 60%. THERE WAS NO TORTUOSITY PRESENT AT THE TARGET VESSEL. THE 12MM X 4CM 80CM P3 .035 POWERFLEX PTA BALLOON CATHETER WAS ADVANCED TO THE PATIENT¿S CENTRAL VEIN AND AN ATTEMPT TO INFLATE THE BALLOON WAS MADE. UPON ATTEMPTED INFLATION, INCOMPLETE BALLOON FILLING WAS OBSERVED, AND THE BALLOON WAS DEFLATED AND REMOVED EASILY, REMAINING IN ONE PIECE DURING REMOVAL. AFTER REMOVING THE POWERFLEX PTA BALLOON CATHETER, A TINY LEAK OF FLUID WAS OBSERVED AT THE DISTAL BALLOON TIP. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14086031 ↗
• MalfunctionApr 11, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 12MM X 4CM 80CM POWERFLEX P3 .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO BE INFLATED AND A LEAK WAS OBSERVED AT THE DISTAL BALLOON TIP. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS UNAVAILABLE, AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073278 ↗
• MalfunctionApr 11, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 12MM X 4CM 80CM POWERFLEX P3 .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO BE INFLATED AND A LEAK WAS OBSERVED AT THE DISTAL BALLOON TIP. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS UNAVAILABLE, AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073239 ↗
• MalfunctionApr 11, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 12MM X 4CM 80CM POWERFLEX P3 .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO BE INFLATED AND A LEAK WAS OBSERVED AT THE DISTAL BALLOON TIP. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS UNAVAILABLE, AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073100 ↗

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