AGENT™ H7493960830200Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506014858), received between Mar 25, 2025 and Mar 25, 2025 — classified as 1 malfunction.
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
- Entrapment of Device1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Break; Entrapment of Device; Failure to Advance; Break; Entrapment of Device; Failure to Advance
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00 X 30MM AGENT BALLOON WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). LESION WAS TREATED WITH 1.25 ROTATIONAL ATHERECTOMY SYSTEM AND BALLOONING WAS PERFORMED WHICH ADEQUATELY PREPPED VESSEL. UPON ATTEMPTED DELIVERY OF THE AGENT BALLOON TO THE DISTAL LAD, BALLOON COULD NOT BE DELIVERED TO THE TREATMENT AREA. THERE WAS ALSO LESION IN MID LAD, BALLOON WAS ELECTED TO BE INFLATED, FOLLOWING INFLATION, BALLOON WAS STUCK ON NON-BSC GUIDEWIRE. AN ATTEMPT WAS MADE TO RETRIEVE, THE BALLOON WAS PULLED BACK INTO THE GUIDE AT WHICH POINT IT BECAME MORE STUCK ON THE WIRE AND THE SHAFT OF THE AGENT BALLOON BROKE. THE WIRE WAS THEN REMOVED WHICH SUCCESSFULLY REMOVED AGENT BALLOON. ANOTHER A 2.00 X 30MM AGENT BALLOON WAS ATTEMPTED TO BE DELIVERED TO THE DISTAL LAD AND A DIFFERENT NON-BSC GUIDEWIRE WAS USED. THE AGENT BALLOON WAS DELIVERED OVER THIS GUIDEWIRE BUT FAILED TO REACH THE DISTAL LAD, THE BALLOON WAS THEN USED TO TREAT ANOTHER MORE PROXIMAL LESION. UPON REMOVAL, THE AGENT BALLOON WAS STUCK ON THE GUIDEWIRE. PROCEDURE WAS COMPL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21687127 ↗
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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