AGENT™ H7493960812250Recalls & reported problems
Boston Scientific Corporation · Paclitaxel-Coated Balloon Catheter · Class 3
All models of AGENT (23)
Data updated Oct 16, 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 00191506014667), received between Nov 13, 2025 and Sep 26, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Deformation Due to Compressive Stress1
- Difficult to Advance1
- Failure to Deflate1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2026Break; Deformation Due to Compressive Stress; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909432 ↗MalfunctionNov 13, 2025Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). A 2.50 X 12 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR LEFT HEART CATHETERIZATION, TARGETING AN IN-STENT RESTENOSIS (ISR) SEGMENT. INTRAVASCULAR ULTRASOUND (IVUS) AND A CUTTING BALLOON WERE UTILIZED PRIOR TO INFLATION OF THE AGENT BALLOON. HOWEVER, THE BALLOON FAILED TO DEFLATE FOLLOWING INFLATION, RESULTING IN A PROLONGED PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23548295 ↗
Other Drug-eluting percutaneous transluminal coronary angioplasty catheter devices
- AGENT™ H7493960830250Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter10 reports
- AGENT™ H7493960830300Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter8 reports
- AGENT™ H7493960820300Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter8 reports
- AGENT™ H7493960830400Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter6 reports
- AGENT™ H7493960820250Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter6 reports
- AGENT™ H7493960830350Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter5 reports
- AGENT™ H7493960815300Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter5 reports
- AGENT™ H7493960820400Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter5 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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