Charger™ H74939206082010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729804642), received between Mar 13, 2019 and Apr 19, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE >70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. AN 8.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6-7 ATMOSPHERES FOR SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 8.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED. HOWEVER, AFTER THE BALLOON WAS BEING INFLATED PRIOR TO REACH THE NOMINAL ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH A 7X60MM ATHLETIS BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769463 ↗
• MalfunctionApr 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE >70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. AN 8.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6-7 ATMOSPHERES FOR SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 8.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED. HOWEVER, AFTER THE BALLOON WAS BEING INFLATED PRIOR TO REACH THE NOMINAL ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH A 7X60MM ATHLETIS BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765611 ↗
• MalfunctionMar 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 8.0 X200, 135CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE FOR A FISTULOGRAM AND AN ARTERIOVENOUS GRAFT. THE CATHETER WAS ADVANCED FOR TREATMENT, HOWEVER, IT WAS NOTED THAT THE BALLOON CAME OFF OF THE CATHETER WHEN PUTTING IT INTO THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8418151 ↗