AGENT™ H7493960815250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00191506014735), received between Oct 3, 2024 and Jul 29, 2026 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient complications occurred.A loading dose of 324 mg of aspirin and 600 mg of clopidogrel were given prior to the procedure. The 8.00 mm x 2.50 mm target lesion was located in the first diagonal branch of the left anterior descending artery (LAD). The target lesion was pre-treated with a 2.50 mm x 15 mm non-compliant balloon angioplasty catheter resulting in 10% residual stenosis and TIMI flow 3. The target lesion was then successfully treated with a 2.50 mm x 15 mm Agent DCB resulting in 0% residual stenosis and TIMI flow of 3. An additional 28 mm x 3.00 mm target lesion located from the proximal to mid LAD was pre-treated with a 2.50 x 15 mm semi-compliant balloon angioplasty catheter resulting in 30% residual stenosis and TIMI flow of 3. The lesion was further treated with a 3.00 mm x 33 mm non-Boston Scientific drug eluting stent resulting in 0% residual stenosis and TIMI flow of 3. A non-target lesion located in the mid right coronary artery (RCA) was successfully treated prior to the treatment of target lesion using a 4.00 mm x 28 mm drug eluting stent and a 4.00 mm x 15 mm balloon angioplasty catheter. Post-procedure, elevated cardiac enzymes were det

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction

  MAUDE report 50073432 ↗
• MalfunctionJul 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071001 ↗
• MalfunctionMar 25, 2026Break; Material Separation

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. AN AGENT US MR 2.50 X 15MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. DURING ADVANCEMENT INTO THE SHEATH, THE END OF THE CATHETER BROKE OFF. AN ALTERNATE DEVICE WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691830 ↗
• MalfunctionOct 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE DEVICE RUPTURED. THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS. A 2.50 X 15 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. AFTER PREPPING THE VESSEL, THE AGENT DEVICE ADVANCED TO THE TARGET LESION. THE BALLOON RUPTURED AFTER 30 SECS OF INFLATION. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER BALLOON. THERE WAS NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360127 ↗