Charger™ H74939206080810Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729804697), received between May 11, 2021 and Nov 17, 2025 — classified as 4 malfunctions.

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

• MalfunctionNov 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 8.0 X 80, 135 CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS RESULTING FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569392 ↗
• MalfunctionFeb 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED BRACHIAL ARTERY. AN 8.0 X80, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324861 ↗
• MalfunctionSep 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WITH A LONG SEGMENT THROMBOSIS WAS LOCATED IN THE COMMON ILIAC VEIN. AFTER THROMBUS REMOVAL, A 8.0 X80, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION, THE PRESSURE PUMP COULD NOT REACH THE WORKING PRESSURE AND A PINHOLE WAS NOTICED ON THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411464 ↗
• MalfunctionMay 11, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN A VESSEL IN THE MODERATELY TORTUOUS AND NON-CALCIFIED BILIARY TRACT. A 8.0 X80, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON COULD NOT BE WITHDRAWN EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806993 ↗