Charger™ H74939206070670Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729804543), received between Mar 28, 2022 and Dec 11, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THERE IS A HOLE IN THE BALLOON OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS BALLOON DILATION OF AN ARTIFICIAL ARTERIOVENOUS FISTULA IN THE LEFT FOREARM, ALONG WITH THROMBOLYSIS OF THE UPPER LIMB VEIN, PERFORMED UNDER LOCAL ANESTHESIA. A 7.0 X60, 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED, AND IMAGING REVEALED ABNORMALITIES. UPON REMOVAL FROM THE PATIENT AND FLUSHING WITH HEPARINIZED SALINE, A VISIBLE DEFECT WAS IDENTIFIED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLAICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901274 ↗
• MalfunctionMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT COMMON ILIAC ARTERY. A 7.0 X60, 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR TREATMENT. IT WAS NOT USED TO POST-DILATE A PREVIOUSLY PLACED STENT. DURING THE PROCEDURE, ON THE FIRST INFLATION PRIOR TO REACHING NOMINAL ATMOSPHERIC PRESSURE FOR SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITH NO FRAGMENTS LEFT INSIDE THE PATIENT AND WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378280 ↗
• MalfunctionFeb 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED FISTULA. A 7.0 X60, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. BURST ATMOSPHERIC PRESSURE WAS 18. HOWEVER, DURING THE THIRD INFLATION AT 14 ATMOSPHERES, THE BALLOON BURSTS. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16321681 ↗
• MalfunctionJan 20, 2023Burst Container or Vessel; Inflation Problem

  BALLOON BURST DURING PROCEDURE. BURST ATMOSPHERIC PRESSURE WAS 18, BALLOON BURST AT 14. THIS WAS THE THIRD INFLATION WITH THIS BALLOON AND BURST ATMOSPHERIC PRESSURE WAS NEVER REACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16226550 ↗
• MalfunctionMar 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7.0 X60, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 3 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED IN A DEFLATED STATE WITH NO INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13926190 ↗