Charger™ H74939206090670Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729804765), received between Jun 24, 2020 and Apr 27, 2022 — classified as 1 injury, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. A CHARGER BALLOON WAS SELECTED FOR USE TO TREAT THE ILIAC ARTERY. THE TARGET VESSEL WAS 70% STENOSED AND MILDLY CALCIFIED. DURING THE FIRST INFLATION AT 12 ATM, THE BALLOON RUPTURED. THE BALLOON WAS EXCHANGED FOR ANOTHER BALLOON. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14228382 ↗
• InjuryJun 24, 2020Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 9.0 X60, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. AN ENCORE PI WAS USED AS AN INFLATION DEVICE. HOWEVER, DURING INFLATION AT 22 ATMOSPHERES, PAST THE APPROPRIATED RATED LIMIT, THE BALLOON RUPTURED AND WAS STUCK IN THE 6FR X 7CM SUPER SHEATH. THEY WERE WORKING OVER A REGULAR ANGLED .035X180 ZIPWIRE. THE BALLOON WOULD NOT COME THROUGH THE SHEATH DUE TO THE RAVELING OF THE PROXIMAL TIP OF THE BALLOON OUTSIDE THE SHEATH IN THE FISTULA. THE DISTAL PART OF THE BALLOON WAS CUT AND THE SHEATH WAS REMOVED WITH BALLOON STILL IN THE VESSEL. THE BALLOON WAS REMOVED USING A 8FR AND 10FR SHEATH. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT ATRIOVENTRICULAR ACCESS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Code Available

  MAUDE report 10190281 ↗