Charger™ H74939206070610Recalls & 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 08714729825500), received between Feb 20, 2019 and Feb 20, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Material Integrity Problem1
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 20, 2019Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem
IT WAS REPORTED THAT THE BALLOON BECAME STUCK TO THE SHEATH. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC. A 7.0 X60, 135CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE. DURING WITHDRAWAL, THE BALLOON DID NOT RE-WRAP APPROPRIATELY AND BECAME STUCK IN THE SHEATH. THE PHYSICIAN REMOVED THE SHEATH, BALLOON AND WIRE AND STARTED THE PROCEDURE OVER BY STENTING THE LESION. THE PROCEDURE WAS SUCCESSFUL WITH NO COMPLICATIONS. THE PATIENT IS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8356454 ↗
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- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
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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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