AGENT™ H7493960812350Recalls & reported problems
Boston Scientific Corporation · Paclitaxel-Coated Balloon Catheter · Class 3
All models of AGENT (23)
Data updated Oct 18, 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 00191506014698), received between Oct 9, 2024 and Oct 27, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Difficult to Advance1
- Entrapment of Device1
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.
MalfunctionOct 27, 2025Break; Break
IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS (ISR), A 3.50 X 12MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE THE SHAFT BROKE. ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE; THERE WAS NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23391564 ↗MalfunctionOct 9, 2024Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance
IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 80% IN-STENT RESTENOSIS (ISR) TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50 X 12MM AGENT DCB BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER TRACKING THROUGH THE NON-BOSTON SCIENTIFIC (NON-BSC) 6F GUIDE CATHETER UP TO THE PRIMARY CURVE, THE AGENT BALLOON WOULD NOT ADVANCE AND APPEARED TO BE STUCK ON THE NON-BSC WIRE. AFTER MULTIPLE ATTEMPTS TO WITHDRAW, BOTH THE WIRE AND THE AGENT BALLOON WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING ANOTHER AGENT BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20408365 ↗
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™ H7493960820250Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter6 reports
- AGENT™ H7493960830400Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter6 reports
- AGENT™ H7493960830350Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter5 reports
- AGENT™ H7493960820400Boston Scientific Corporation · Drug-eluting percutaneous transluminal coronary angioplasty catheter5 reports
- AGENT™ H7493960815300Boston 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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