Charger™ H74939206051010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729804154), received between Feb 14, 2020 and Dec 22, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN SUPERFICIAL FEMORAL ARTERY. A 5.0 X100, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES INSIDE THE PATIENT'S BODY, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED OVER THE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034798 ↗
• MalfunctionDec 14, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT FROZE ON WIRE OCCURRED. A 5.0 X100, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. THE PHYSICIAN INFLATED THE BALLOON AND REMOVED IT OFF THE WIRE. HOWEVER, WHEN IT WAS USED LATER, THE BALLOON GOT STUCK TO THE WIRE AND WOULD NOT LOAD PROPERLY. THE PHYSICIAN WAS ABLE TO WALK THE BALLOON OFF THE WIRE WITH CONSIDERABLE RESISTANCE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BALLOON WITH THE SAME GUIDEWIRE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11003864 ↗
• MalfunctionFeb 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X100, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE DEVICE WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714924 ↗