Charger™ H74939206071510Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729804468), received between Jul 11, 2019 and May 4, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND NON-TORTUOUS MID SUPERFICIAL FEMORAL ARTERY. A 7.0 X150, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CHARGER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773276 ↗
• MalfunctionJul 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. TWO 7.0 X200MM, 135CM AND A 7.0 X150MM, 135CM CHARGER BALLOON CATHETERS WERE USED SUBSEQUENTLY FOR DILATATION. HOWEVER, THE BALLOONS WOULD NOT HOLD THE PRESSURE AND RUPTURED. BLOOD WAS IN THE INDEFLATOR UPON INFLATION AND IT WAS NOTED THAT THERE WAS A RIP. THE PROCEDURE WAS COMPLETED WITH A 4.0 BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780739 ↗