Charger™ H74939206070410Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729804529), received between May 21, 2019 and Aug 12, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7.0 X40, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING SECOND INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 7.0 X40, 135CM CHARGER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218928 ↗
• MalfunctionMay 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X40, 135CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A LONGER LENGTH DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656837 ↗
• MalfunctionMay 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 7.0MM X40MM, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE AFTER A COUPLE INFLATIONS, THE BALLOON BURST AT NOMINAL PRESSURE BETWEEN 4 AND 6 ATMOSPHERE. THE DEVICE WAS COMPLETELY REMOVED OVER THE WIRE. THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628045 ↗