Charger™ H74939206050410Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729804246), received between Apr 8, 2022 and Nov 24, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED. A 5.0 X40, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING THE RATED PRESSURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20768088 ↗
• InjuryOct 3, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. THIS 5.0 X 40, 135CM CHARGER BALLOON AND NON-BOSTON SCIENTIFIC 5F INTRODUCER WAS SELECTED FOR TREATMENT OF SPINAL MUSCLE ATROPHY OF THE CELIAC TRUCK. THE PROCEDURE WENT AS EXPECTED; HOWEVER, DURING REMOVAL THE BALLOON WAS NOT ABLE TO BE DEFLATED. THE PHYSICIAN WAS UNSUCCESSFUL AT ATTEMPTING TO USE A "DILATOR HANDLE" TO REMOVE. AT LAST, THEY WITHDREW THE BALLOON TOGETHER WITH THE INTRODUCER. THIS CAUSED A BIGGER "ENTRANCE HOLE" THAN NORMAL AND TOOK ADDITIONAL TIME AND SUTURES TO CLOSE THE ACCESS POINT. THE PATIENT WAS REPORTED AS FULLY RECOVERED.

  Patient problems: Perforation of Vessels

  MAUDE report 20361430 ↗
• MalfunctionApr 8, 2022Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0 X40, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. AFTER INFLATION, THE DEVICE WAS ATTEMPTED TO BE REMOVED OVER THE GUIDE WIRE. HOWEVER, THE WIRE WAS LOCKED ONTO THE DEVICE. BOTH THE BALLOON AND WIRE WERE REMOVED TOGETHER AS A UNIT. FURTHERMORE, A KINK NEAR THE HUB WAS NOTED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052972 ↗