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Charger™ H74939206061070Recalls & 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 08714729804307), received between Aug 4, 2021 and Aug 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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

  • Device Markings/Labelling Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 4, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT THE DEVICE PACKAGING HELD THE INCORRECT CONTENT. DURING PREPARATION FOR A PROCEDURE, A 6MMX100MMX75CM CHARGER BALLOON CATHETER BOX WAS OPENED FOR USE AND IT WAS NOTED THAT THE WRONG SIZE BALLOON HAD BEEN PLACED IN THE BOX, THE BALLOON CATHETER INSIDE THE BOX WAS SIZE 7MMX40MMX75CM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER BALLOON. THE PATIENT IS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12278477 ↗

Other CATHETER, BILIARY, DIAGNOSTIC devices

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Sources and updates

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