POWERFLEX 4400610XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032059586), received between Aug 28, 2019 and Mar 4, 2022 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 10CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION TO 6 ATMOSPHERES (ATM). THE SABER PTA BALLOON CATHETER WAS REMOVED, AND A 6MM X 10CM 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INSERTED AND INFLATED TO 10 ATM WHEN THE BALLOON OF THE POWERFLEX PRO PTA BALLOON CATHETER RUPTURED AS WELL. THERE WAS NO REPORTED INJURY TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF AN UNKNOWN STENT. THIS WAS DURING A PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO TARGET VESSEL TORTUOSITY OR PRESENCE OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS FOR BOTH DEVICES, AND BOTH DEVICES WERE ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. A 50/50 CONTRAST AND SALINE MIXTURE WAS USED TO PREPARE THE BALLOONS. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED WHILE INSERTING THE DEVICES INTO THE PATIENT. THERE WAS NO DIFFICULTY EXPERIENCED WHILE ADVANCING THE DEVICES TOWARDS THE LESIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673439 ↗
• MalfunctionDec 9, 2020Difficult to Remove; Difficult to Remove

  DURING INTERVENTION FOR BILATERAL STAGE IIB PERIPHERAL ARTERY DISEASE (PAD), IT WAS DIFFICULT TO FLUSH THE 6MM X 10CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) BECAUSE ¿THE RINSE LIGHT IS INSUFFICIENT¿. THE CATHETER COULD STILL BE RINSED, AND THE BALLOON COULD BE INFLATED. HOWEVER, IT WAS COMPLICATED TO WITHDRAW THE CATHETER AFTER DILATION. IT WAS NOT POSSIBLE TO REMOVE THE BALLOON CATHETER WITH THE GUIDEWIRE. THE GUIDEWIRE HAD TO BE REMOVED AND THEN IT WAS POSSIBLE TO REMOVE THE BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS IN CARE SURGERY. IT WAS MENTIONED THAT THERE WAS DELAY IN PROCEEDINGS. THERE WAS NO CONSEQUENCE IN THE CLINIC FOR THE PATIENT. REPORTER SAID THERE WAS RISK OF JAMMING THE CATHETER IN SITU. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976427 ↗
• MalfunctionNov 18, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6MM X 10CM X 135CM POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS DIFFICULT TO REACH THE LESION. IT REACHED SOMEHOW BUT IT RUPTURED AT THE LESION. THEREFORE, IT WAS REPLACED WITH A NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10861387 ↗
• MalfunctionAug 28, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A POWERFLEX PRO 6MM X 10CM 135 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) BALLOON INFLATED BUT IT RUPTURED AT 4 ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940694 ↗