Charger™ H74939206052010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729804222), received between Jun 4, 2020 and Jun 19, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 5.0 X200, 135CM CHARGER BALLOON WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON BURST AT NOMINAL PRESSURE WHILE BALLOON PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED. THE BALLOON WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565588 ↗
• MalfunctionNov 23, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. IT WAS NOTED THAT THE BALLOON WAS HELD AT NOMINAL ATMOSPHERES FOR ONE MINUTE DURING INFLATION. HOWEVER, AFTER SUCCESSFUL INFLATION, THE BALLOON FAILED TO DEFLATE. THE PHYSICIAN TRIED TO USE DIFFERENT SYRINGES TO DRAW OUT SOLUTION AND WERE ABLE TO GET DOWN ENOUGH TO PULL IT OUT OF THE SHEATH. THE DEVICE WAS REMOVED FULLY INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10885275 ↗
• MalfunctionJul 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION IN A LEG ANGIOGRAM. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY OVER THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289555 ↗
• MalfunctionJun 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10197739 ↗
• MalfunctionJun 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE NOMINAL BALLOON PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY AND THE BALLOON RUPTURED DURING THE FIRST INFLATION BELOW THE NOMINAL PRESSURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118569 ↗