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Charger™ H74939206060470Recalls & 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 08714729804390), received between Dec 7, 2018 and Dec 7, 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.

  • MalfunctionDec 7, 2018Material Rupture; Material Rupture

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 6.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CHARGER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8142653 ↗

Other CATHETER, BILIARY, DIAGNOSTIC devices

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Sources and updates

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