Charger™ H74939206080670Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729804680), received between Oct 2, 2018 and Aug 28, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• InjuryAug 28, 2024Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT INTERVENTION WAS PERFORMED AFTER THE BALLOON RUPTURED. AN 8.0 X60, 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR TREATMENT. POST-DILATION, AT 20 ATMOSPHERES, THE BALLOON RUPTURED. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE MATERIAL WAS FRAGMENTED AND SHEARED OFF OF THE CATHETER. THE PHYSICIAN PERFORMED SNARING IN AN ATTEMPT TO REMOVE THE REMAINING MATERIAL BUT WAS UNSUCCESSFUL. THE PHYSICIAN PLACED A NON-BSC SELF-EXPANDING STENT GRAFT TO TRAP THE BALLOON FRAGMENT BETWEEN THE GRAFT AND THE LUMEN AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20091340 ↗
• InjuryApr 25, 2023Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. AN 8.0 X60, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON MATERIAL BURST, DETACHED, AND MOVED TO THE PROXIMAL END OF THE CATHETER. WHILE ATTEMPTING TO PULL THE DEVICE THOUGH THE SHEATH, THE BALLOON MATERIAL DETACHED AND REMAINED INSIDE THE PATIENT. TO PREVENT FROM FURTHER POSSIBLE MIGRATION, A STENT WAS PLACED OVER THE UNRETRIEVED BALLOON MATERIAL AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED. THE PATIENT WILL UNDERGO A FISTULA REVISION AND THE UNRETRIEVED BALLOON MATERIAL WILL BE REMOVED BY THEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16812465 ↗
• MalfunctionAug 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8.0 X60, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10400796 ↗
• MalfunctionOct 12, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY. A 8.0 X60, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 4 ATMOSPHERES THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7961653 ↗
• MalfunctionOct 2, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT TWO BALLOONS BURST. DURING A TREATMENT PROCEDURE OF A CHRONIC TOTAL OCCLUTION (CTO) IN THE RIGHT ILIAC VEIN. THE PHYSICIAN USED AN ULTRA ICE PLUS IMAGING CATHETER BUT WAS NOT ABLE TO CROSS THE STENOSIS. THE IMAGING CATHETER WAS CHANGED FOR AN OPTICROSS 18 IVUS DEVICE WHICH WORKED WITHOUT ANY PROBLEM. DURING THE PROCEDURE A WALLSTENT WAS IMPLANTED AND TWO BALLOON CATHETERS (CHARGER BALLOON AND THE XXL BALLOON) WERE USED BUT RUPTURED. THE BALLOONS WERE REMOVED INTACT AND NOTHING LEFT BEHIND IN THE PATIENT. THEY USED ANOTHER OF THE SAME BALLOON TO COMPLETE THE CASE. THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926143 ↗