Charger™ H74939206080870Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729804703), received between Aug 30, 2018 and Mar 6, 2025 — classified as 1 injury, 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 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.

• MalfunctionMar 6, 2025Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 17FEB2025. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS ILIAC VEIN. A 8.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION.DURING THE PROCEDURE, THE PRESSURE PUMP WAS UTILIZED TO INFLATE THE DEVICE TO 10 ATMOSPHERES HOWEVER, IT FAILED TO INFLATE. THE PHYSICIAN SUBSEQUENTLY WITHDREW THE INTACT PRODUCT FROM THE PATIENTS BODY AND REPLACED IT WITH AN IDENTICAL DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, THE DEVICE ANALYSIS REVEALED A PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540698 ↗
• MalfunctionNov 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE GREATER THAN 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON FEMORAL ARTERY. AN 8.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 10 ATMOSPHERES IN LESS THAN 1 MINUTE, THE BALLOON BURST. THE DEVICE WAS REMOVED AND THERE WERE NO FRAGMENTS LEFT IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER 8MM X 100MM X 75CM CHARGER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798367 ↗
• InjuryJul 22, 2021Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. AN 8MM X 80MM CHARGER BALLOON WAS SELECTED FOR USE IN AN INTERVENTION IN THE ILIAC. THE TARGET LESION WAS MODERATELY TO SEVERELY CALCIFIED. DURING PRE-DILATATION, THE BALLOON BURST AT 10ATM ON THE SECOND INFLATION. OPEN SURGERY WAS REQUIRED. THE BALLOON WAS SUCCESSFULLY REMOVED. NO DEVICE FRAGMENTS REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS IN GOOD CONDITION FOLLOWING SURGERY AND WAS DISCHARGED. THE PATIENT FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE BALLOON COULD NOT BE RETRACTED THROUGH THE SHEATH. THEREFORE, SURGERY WAS NEEDED TO REMOVE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215448 ↗
• MalfunctionAug 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUBCLAVIAN ARTERY. A 8.0 X 80, 75 CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8867720 ↗
• MalfunctionAug 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 8.0X80, 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, IT WAS NOTED THAT THE BALLOON WAS DETACHED FROM THE CATHETER, OUTSIDE THE PATIENT'S BODY. THE PROCEDURE COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832273 ↗