AGENT™ H7493960820350Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00191506014834), received between Aug 15, 2024 and Jun 29, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Material Rupture2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Break
IT WAS REPORTED THAT SHAFT BROKE. A 3.50 X 20MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING PROCEDURE, THE SHAFT BROKE RIGHT PROXIMAL TO BALLOON ON ADVANCING. THE PROCEDURE WAS COMPLETED WITH ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25654078 ↗MalfunctionFeb 18, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. AN AGENT US MR 3.50 X 20MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. DURING THE PROCEDURE, AS THE BALLOON WAS INITIALLY INFLATED IT BURST. ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24381414 ↗MalfunctionSep 8, 2025Break; Break
IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 3.50 X 20MM AGENT DCB WAS SELECTED FOR USE. THE SHAFT BROKE DURING ADVANCEMENT INSIDE THE BODY AND THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22992731 ↗MalfunctionAug 15, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURED. A 3.50 X 20MM AGENT DCB BALLOON WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. DURING PROCEDURE, ON INFLATION BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE. PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19991246 ↗
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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