POWERFLEX 4209040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032004944), received between Mar 15, 2021 and Sep 17, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2022Leak/Splash; Leak/Splash

  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 15443118 ↗
• InjuryMar 15, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  THE PHYSICIAN WAS TRYING TO OPEN A STENOSIS IN FISTULA WHEN THE TIP OF A 9MM X 40MM X 80CM POWERFLEX P3 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BROKE FREE FROM THE DEVICE. THEY USED A NON-CORDIS SNARE KIT TO REMOVE THE SHAFT/HYPOTUBE OF THE BALLOON; HOWEVER, A PIECE OF THE BALLOON ITSELF REMAINED IN THE PATIENT. THE PATIENT WAS SENT TO VASCULAR SURGERY IMMEDIATELY, WHERE THE RETAINED PART OF THE BALLOON WAS SUCCESSFULLY RETRIEVED. THE FISTULA WAS NOT SALVAGED. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE DEVICE WAS PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED DURING PREP. ALL USERS INVOLVED WERE VERY EXPERIENCED WITH THE DEVICE. THE FISTULA WAS SEVERELY CALCIFIED, MODERATELY TORTUOUS, HAD MODERATE ANGULATION WITH AN 80-90% STENOSIS MID FISTULA. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. THE SEPARATION OCCURRED DURING INFLATION, APPROXIMATELY 1CM FROM THE DISTAL END. THE BALLOON WAS INFLATED TO 10ATMS. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE NOR WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11480258 ↗

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