Charger™ H74939206040410Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729804109), received between Jan 8, 2019 and Jan 8, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN TWO DIFFERENT VESSEL LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND TIBIAL PERONEAL TRUNK. A 4.0MM X 40MM X 135CM CHARGER BALLOON CATHETER WAS ADVANCED IN THE SFA, BUT THE BALLOON RUPTURED. THE DEVICE WAS REPLACED WITH A 3MM X 40MM X 145CM COYOTE ES BALLOON CATHETER AND IT WORKED OKAY. THEN THEY WORKED ON A LOWER VESSEL THAT WAS MEASURED VIA INTRAVASCULAR ULTRASOUND. A 3MM X 40MM X 145CM AND 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETERS WERE ADVANCED IN THE TIBIAL PERONEAL TRUNK BUT ALSO RUPTURED. THE BALLOON CATHETERS WERE REMOVED AND THEY TRIED INFLATING THEM OUTSIDE THE PATIENT'S BODY. IT WAS NOTED THAT THERE WAS AN INCISION THAT IT LOOKS LIKE IT WAS POKED THROUGH. THE PROCEDURE WAS COMPLETED WITH A HALF SIZE UP OR HALF SIZE DOWN FROM THE THIRD BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8226577 ↗