AGENT™ H7493960815300Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00191506014759), received between Mar 3, 2025 and Apr 24, 2026 — classified as 1 injury, 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Material Separation

  IT WAS REPORTED THAT THE BALLOON CAME OFF THE SHAFT. A 3.00 MM X 15.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR A CORONARY ARTERY DISEASE (CAD) TREATMENT. DURING THE PROCEDURE, THE BALLOON CAME OFF THE SHAFT. THE DEVICE WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981825 ↗
• MalfunctionJul 25, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BROKE. A 3.00 X 15MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR TREATING IN-STENT RESTENOSIS. DURING PROCEDURE, AFTER LOADING ONTO GUIDEWIRE AND ADVANCING THE BALLOON TO THE LESION, THE SHAFT BROKE. DEVICE WAS REMOVED COMPLETELY WITH NO ISSUE. THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613357 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS AND A MYOCARDIAL INFARCTION OCCURRED. THE PATIENT WAS PRESENTED WITH IN-STENT RESTENOSIS. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND VERY MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION FIRST PREPPED WITH A 2.50 X 15 NC EMERGE BALLOON, FOLLOWED BY A 3.00 X 15 NON-BOSTON SCIENTIFIC BALLOON. TREATMENT OF THE RESTENOSIS WAS COMPLETED USING A 3.00 X 15MM AGENT DRUG-COATED BALLOON (DCB), YIELDING EXCELLENT RESULTS. THE PROCEDURE WAS INITIALLY CONCLUDED, AND THE PATIENT WAS TAKEN OFF THE TABLE. HOWEVER, APPROXIMATELY AN HOUR LATER, THE PATIENT EXPERIENCED EKG CHANGES AND CHEST PAIN. UPON RE-EVALUATION, AN ACUTE OCCLUSION OF THE LEFT ANTERIOR DESCENDING ARTERY WAS IDENTIFIED, ALONG WITH ACUTE THROMBOSIS AND A MYOCARDIAL INFARCTION IN THE PREVIOUSLY TREATED MID-SEGMENT. A 2.50 X 48 MM STENT WAS PLACED, FOLLOWED BY POST-DILATION WITH A 3.00 X 20 NC EMERGE BALLOON. THE PATIENT RECOVERED WELL, REMAINED UNDER OBSERVATION OVERNIGHT AND WAS DISCHARGED THE NEXT DAY WITHOUT COMPLICATIONS, HAVING MADE A FULL RECOVERY.

  Patient problems: Chest Pain; Myocardial Infarction; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 22378500 ↗
• MalfunctionJun 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST. A 3.00 X 15MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297590 ↗
• MalfunctionMar 3, 2025Break; Break

  IT WAS REPORTED THAT THE BALLOON DETACHED. AN AGENT US MR 3.00 X 15MM WAS SELECTED FOR TREATMENT OF THE SEVERELY CALCIFIED, SEVERELY TORTUOUS, AND 80% STENOSED TARGET LESION. WHILE THE BALLOON WAS BEING INSERTED, THE PHYSICIAN NOTED THAT THE SHAFT OF THE DEVICE FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS UNABLE TO BE COMPLETED DUE TO THIS. THE PATIENT WAS UNDER LOCAL ANESTHESIA AT THE TIME THE PROCEDURE WAS CANCELLED, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21507907 ↗