AGENT™ H7493960815200Recalls & 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 00191506014711), received between Sep 8, 2026 and Sep 8, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
- Packaging Problem1
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.
MalfunctionSep 8, 2026Contamination; Packaging Problem
It was reported that device contamination occurred.Upon arrival to the facility, a 2.00 x 15mm Agent DCB was discovered to have damage to the outer box and the inner packaging was ripped open, compromising the sterility of the device. The shipping box was also noted to be damaged as well. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674697 ↗
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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