AGENT™ H7493960815400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506014773), received between May 5, 2025 and Aug 19, 2026 — classified as 3 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.

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.

• MalfunctionAug 19, 2026Break; Difficult to Advance

  It was reported that a shaft break occurred.The 90% stenosed target lesion was located in a moderately tortuous and severely calcified distal right coronary artery (RCA). A 4.00 mm x 15.00 mm Agent drug coated balloon (DCB) was selected for treatment. During the procedure, while the physician was advancing the balloon, it snapped at the mid shaft. The device was removed as a single unit, and the procedure was completed using a different device.It was further reported that the user encounter resistance while advancing the device. It was fractured on the balloon shaft. And there was no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334625 ↗
• MalfunctionMay 12, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 4.00 MM X 15.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150240 ↗
• MalfunctionMay 5, 2025Contamination; Contamination

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A 4.00 X 15MM AGENT DCB BALLOON WAS SELECTED FOR IN-STENT RESTENOSIS PERCUTANEOUS CORONARY INTERVENTION (ISR PCI) PROCEDURE. DURING PREPARATION, BALLOON BECAME CONTAMINATED ON THE FIELD AFTER OPENING. PROCEDURE WAS COMPLETED USING NEW AGENT DCB BALLOON AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959887 ↗