AGENT™ H7493960830270Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506014889), received between Dec 3, 2025 and Sep 30, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Adverse Event Without Identified Device or Use Problem1
- Device-Device Incompatibility1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Vascular Dissection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Vascular Dissection
MAUDE report 50948445 ↗MalfunctionDec 3, 2025Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility
IT WAS REPORTED THAT THE DEVICE FROZE ON THE WIRE. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). A 2.75 MM X 30.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING DELIVERY OF THE BALLOON THROUGH THE GUIDEWIRE AND INTO THE VESSEL, THE BALLOON FAILED TO TRACK PROPERLY OVER THE GUIDEWIRE AND BECAME STUCK TO IT UPON ADVANCEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER AGENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708710 ↗
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 13, 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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