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Charger™ H74939206060410Recalls & 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 08714729804383), received between Feb 21, 2020 and Feb 21, 2020 — 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.

  • MalfunctionFeb 21, 2020Material Rupture; Material Rupture

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X40, 135CM CHARGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE BALLOON WAS INFLATED AT NOMINAL PRESSURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9739943 ↗

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Sources and updates

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