AGENT™ H7493960815350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506014766), received between Jul 3, 2025 and Mar 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 3.50 MM X 15.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR TREATMENT OF IN-STENT RESTENOSIS (ISR). DURING REMOVAL, THE SHAFT OF THE BALLOON CATHETER FRACTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730372 ↗
• MalfunctionDec 9, 2025Break; Entrapment of Device; Deformation Due to Compressive Stress; Device-Device Incompatibility; Break; Entrapment of Device; Deformation Due to Compressive Stress; Device-Device Incompatibility

  IT WAS REPORTED THAT DEVICE ENTRAPPED AND SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A 3.50 X 15 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING INSERTION, THE BALLOON BECAME STUCK WITHIN THE GUIDE EXTENSION, RESULTING IN SHAFT BENT AND BRAKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756759 ↗
• MalfunctionJul 3, 2025Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. AN AGENT US MR 3.50 X 15MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION, WHICH WAS LOCATED IN THE PROXIMAL CIRCUMFLEX. FOLLOWING IVUS, THE PHYSICIAN BEGAN ATTEMPTING TO ADVANCE THE AGENT BALLOON. IT WAS NOTED THAT THERE WAS DIFFICULTY ADVANCING THE BALLOON. WHEN ATTEMPTING TO PROPERLY POSITION THE BALLOON, THE PROXIMAL END OF THE DEVICE BROKE, JUST BEFORE THE BALLOON. THE PHYSICIAN WAS ABLE TO COMPLETELY REMOVE THE AGENT FROM THE PATIENT, AND ANOTHER SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395731 ↗