AGENT™ H7493960812300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00191506014681), received between Apr 21, 2025 and Aug 19, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Break; Failure to Advance

  It was reported that a shaft break within a patient occurred. A 3.00 mm x 12mm AGENT US MR was selected for a Percutaneous Coronary Intervention to evaluate the target lesion. During the procedure, the device could not advance in the lesion and the shaft subsequently broke. The procedure was completed as planned and the device was successfully removed in one piece from the patient. No patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334624 ↗
• MalfunctionMay 4, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE BALLOON KINKED AND THE SHAFT BROKE. A 3.00 MM X 12.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR TREATMENT. DURING ADVANCEMENT OF THE DEVICE INTO THE PATIENT, THE SHAFT KINKED AND SUBSEQUENTLY BROKE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070664 ↗
• MalfunctionJul 2, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 12MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. DURING PROCEDURE, BALLOON SHAFT BROKE. DEVICE WAS REMOVED OUT OF PATIENT AND NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE AND THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383075 ↗
• MalfunctionApr 21, 2025Break; Entrapment of Device; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Entrapment of Device; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER FROZE ON WIRE OCCURRED. A 3.00 X 12MM AGENT DCB BALLOON WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION PROCEDURE TO TREAT CORONARY ARTERY DISEASE AND IN-STENT RESTENOSIS. DURING THE PROCEDURE, WHEN THE PHYSICIAN ADVANCED THE BALLOON, IT WAS NOT NOTED THAT THE BALLOON PROTECTOR WAS STILL ON THE DEVICE. THE COVER WOULD NOT ADVANCE THROUGH THE TOUHY. THE PHYSICIAN TRIED TO PEEL AWAY THE COVER WHILE THE DEVICE WAS ON THE GUIDEWIRE BUT WAS NOT SUCCESSFUL. THE COVER HAD BEEN PUSHED TO THE MONORAIL EXIT PORT OF THE BALLOON AND THE BALLOON WAS STUCK ON THE GUIDEWIRE. DURING ATTEMPTS TO REMOVE THE BALLOON FROM THE GUIDEWIRE OUTSIDE THE PATIENT, THE BALLOON MONORAIL/HYPOTUBE BROKE AWAY FROM THE SHAFT AND THE GUIDEWIRE ALSO SNAPPED. THE PROCEDURE WAS COMPLETED USING A NEW GUIDEWIRE AND A NEW AGENT BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876972 ↗