Charger™ H74939206060210Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729804345), received between Oct 5, 2018 and Mar 17, 2023 — classified as 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
Device problems
- Entrapment of Device1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X20, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON BURST BEFORE REACHING THE MAXIMUM BURST PRESSURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16569006 ↗MalfunctionOct 5, 2018Entrapment of Device; Entrapment of Device
IT WAS REPORTED THE CATHETER GOT STUCK ON THE GUIDEWIRE. TREATMENT WAS BEING PERFORMED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS A LONG CASE, WHICH THE PHYSICIAN WAS USING A ZIPWIRE. THE ZIPWIRE HAD BEEN IN THE PATIENT FOR A LONG TIME (GREATER THAN 20 MINUTES). WHEN THE PHYSICIAN ADVANCED A 6.0 X20 CHARGER BALLOON OVER THE ZIPWIRE IT GOT STUCK. BOTH THE CHARGER AND ZIPWIRE WERE REMOVED FROM THE PATIENT TOGETHER. ONCE OUTSIDE OF THE PATIENT, SALINE WAS APPLIED AND THE TWO SEPARATED. THE ZIPWIRE WAS THEN ADVANCED AGAIN INTO THE PATIENT. THE WIRE WETTED BETWEEN EACH DEVICE ADVANCEMENT. ANOTHER BALLOON CATHETER WAS ADVANCED AND WORKED FINE. THE PROCEDURE WAS COMPLETED WITH AN INNOVA STENT WITH NO COMPLICATIONS TO THE PATIENT. THE PATIENT WAS NOTED TO BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7937890 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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