Charger™ H74939206080410Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729804666), received between Mar 25, 2019 and Feb 2, 2026 — 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.

• MalfunctionFeb 2, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR UNDER GENERAL ANESTHESIA. VASCULAR ACCESS WAS OBTAINED UNDER B-ULTRASOUND GUIDANCE, AND AN 8.0 X 40, 135 CM CHARGER BALLOON CATHETER WAS ADVANCED TO PERFORM THE FENESTRATION PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE THE RATED BURST PRESSURE WAS REACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240859 ↗
• MalfunctionNov 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. AN 8.0 X40, 135CM CHARGER WAS SELECTED FOR USE IN ANGIOPLASTY. HOWEVER, DURING INFLATION, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622840 ↗
• MalfunctionJan 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE THORACIC AORTA. AN 8.0 X40, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476513 ↗
• MalfunctionMar 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT CONTAMINATION AND BALLOON RUPTURE OCCURRED. A 6X60X120 EPIC VASCULAR STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE STENT WAS CONTAMINATED BY TECHNOLOGIST. ANOTHER EPIC STENT OF AN UNKNOWN SIZE WAS SUCCESSFULLY USED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. AFTER AN UNKNOWN EPIC STENT WAS DEPLOYED, A 8.0 X40, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND 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 9848396 ↗
• MalfunctionMar 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE POPLITEAL VEIN. A 8.0 X40, 135CM CHARGER BALLOON CATHETER WAS WAS SELECTED TO DILATE THE LESION. THE BALLOON WAS INFLATED THREE TIMES, BETWEEN 8 AND 10 ATMOSPHERES EACH TIME. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE BALLOON OUT OF THE 6FR SHORT NON-BSC SHEATH BUT THE BALLOON WOULD NOT COME OUT. THE PHYSICIAN CONTINUED TO PULL ON IT AND THE BALLOON DETACHED FROM THE SHAFT INSIDE THE SHEATH. THE SHEATH WAS REMOVED WHICH HAD THE DETACHED BALLOON STUCK IN IT AND EVERYTHING WAS REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8449846 ↗