Charger™ H74939206060810Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729804413), received between Jul 23, 2021 and Oct 19, 2022 — 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 16, 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.

• MalfunctionOct 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X80, 135CM CHARGER BALLOON CATHETER WAS PREPPED AND ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, CONTRAST WAS SEEPING OUT AND A HOLE WAS NOTED IN THE BALLOON. THE DEVICE WAS REMOVED, AND A NEW CHARGER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633722 ↗
• MalfunctionAug 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 80, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15212894 ↗
• MalfunctionAug 11, 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 ILIAC ARTERY. A 6.0 X80 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 8 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15212403 ↗
• MalfunctionJul 23, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DEVICE LABELING ISSUE OCCURRED. A 6.0 X80, 135CM CHARGER BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT WRONG SIZE BALLOON WAS INSIDE THE BOX. THE BOX WAS SEALED BEFORE IT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217707 ↗