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Charger™ H74939206050470Recalls & reported problems

Boston Scientific Corporation · PTA Balloon Dilatation Catheter · Class 2

All models of Charger (49)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729804253), received between Nov 20, 2018 and Nov 20, 2018 — 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

Device problems

  • Material Rupture1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 20, 2018Material Rupture; Material Rupture

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT SUPERFICIAL ARTERY. A 5.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION PRIOR TO REACHING THE NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8089092 ↗

Other CATHETER, BILIARY, DIAGNOSTIC devices

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Sources and updates

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