Charger™ H74939206081010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729804574), received between Sep 25, 2019 and Jul 27, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN 8.0 X100, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 8X100 CHARGER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AT 10 ATMOSPHERES AND THE DEVICE WAS COMPLETELY REMOVED THROUGH SHEATH USING STANDARD EXTRACTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232736 ↗
• MalfunctionSep 25, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT FEMORAL VEIN. A 8.0 X100, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. AFTER THE LAST INFLATION, THE BALLOON WAS TOTALLY DEFLATED; HOWEVER, WHEN THE DEVICE WAS PULLED OUT, THE BALLOON CATHETER BECAME STUCK ABOUT HALF WAY THROUGH THE INTRODUCER SHEATH. THE CATHETER BROKE IN TWO AT THE CONNECTION BETWEEN THE BALLOON AND THE CATHETER. THE BROKEN PARTS WERE RETRIEVED AS IT CAME OUT WITH THE SHEATH. VENOGRAM WAS TAKEN AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119523 ↗