AGENT™ H7493960820220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506014797), received between Jul 21, 2025 and Feb 23, 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.

• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 2.25 MM X 20.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR USE DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). DURING THE PROCEDURE, WHILE ATTEMPTING TO DELIVER THE AGENT DCB TO THE LESION SITE, THE SHAFT BROKE. THE DEVICE WAS REMOVED FROM PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS IN GOOD CONDITION AND FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413034 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS VESSEL. A 2.25 X 20 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PROCEDURE. WHILE ADVANCING THE AGENT BALLOON, THE MIDSECTION OF THE HYPOTUBE SNAPPED INTO TWO SEPARATE PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596281 ↗
• MalfunctionJul 21, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BROKE. A 2.25 MM X 20.00 MM AGENT DRUG COATED BALLOON (DCB) WAS SELECTED FOR TREATING IN-STENT RESTENOSIS (ISR). DURING DELIVERY OF THE BALLOON, RESISTANCE WAS MET TRYING TO CROSS THE LESION AND THE SHAFT BROKE. DEVICE WAS EASILY REMOVED, AND PROCEDURE WAS COMPLETED USING ANOTHER OF SAME DEVICE. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22558384 ↗