Charger™ H74939206041010Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729804017), received between Dec 13, 2019 and Dec 13, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
- Low Blood Pressure/ Hypotension1
- No Code Available1
- Tachycardia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED TACHYCARDIA AND HYPERTENSION. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 4.0X100, 135CM CHARGER BALLOON CATHETER WAS CROSSED THE LESION AND DILATION WAS PERFORMED IN TWO INFLATIONS TO NOMINAL. HOWEVER, WHEN THE DEVICE WAS REMOVED, THE PATIENT BECAME TACHYCARDIC AND HYPOTENSIVE. THE PATIENT WAS PUT ON PRESSURES, MEDICATION AND GET THE BLOOD PRESSURE UP AND STABLE. THE PROCEDURE WAS STOPPED AFTER BALLOONING DUE TO THE PATIENT'S REACTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WILL HAVE SURGERY TO CORRECT THE SFA LESION. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 100% IN-STENT STENOSIS, FIBROUS WITH PLAQUE WHICH EXTEND DISTAL TO THE STENT LOCATED IN THE DISTAL SFA AND PROXIMAL POPLITEAL ARTERY. IT WAS AROUND 5 MINUTES AFTER BALLOON REMOVAL THAT THE PATIENT BECAME HYPOTENSIVE AND TACHYCARDIAC. THE PATIENT HAD AN ALLERGIC REACTION TO BALLOON COATING. IT WAS BELIEVED THE PATIENT MAY OR HAD A REACTION TO EITHER THE CONTRAST OR SEDATION AT THIS TIME. THE PATIENT WAS PREMEDICATED TO HELP PREVENT ANOTHER POSSIBLE REACTION.
Patient problems: Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; No Code Available; Tachycardia
MAUDE report 9466342 ↗
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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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