AGENT™ H7493960820400Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00191506014841), received between Dec 15, 2025 and May 28, 2026 — classified as 1 injury, 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Break; Fluid/Blood Leak; Inflation Problem; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN MODERATELY CALCIFIED AND TORTUOUS LEFT MAIN AND CIRCUMFLEX BIFURCATION. THE LESION WAS PREPARED WITH AN NC EMERGE BALLOON. A 4.00 X 20MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) AND WAS DELIVERED TO LESION EASILY. AS THE PHYSICIAN STARTED TO INFLATE THE BALLOON, IT WOULD NOT COME TO PRESSURE AND THERE WAS LEAK. PHYSICIAN APPLIED A NEGATIVE PRESSURE AND STARTED TO REMOVE BALLOON, ON WITHDRAWING THE BALLOON SHAFT FULLY BROKE. THE BALLOON CATHETER WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318073 ↗
• MalfunctionMar 3, 2026Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT WIRE BECAME STUCK WHILE LOADING. DURING THE PROCEDURE A 4.00 MM X 20.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR TREATMENT. DURING THE INSERTION, BEFORE IT ENTERED TO THE BODY, WHILE LOADING THE BALLOON, IT GOT STUCK WITH THE GUIDE WIRE. THE BALLOON AND THE GUIDE WIRE DEVICE WERE REMOVED FROM PATIENT AS A SINGLE UNIT WITHOUT PATIENT COMPLICATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501037 ↗
• MalfunctionFeb 27, 2026Break; Failure to Advance; Deformation Due to Compressive Stress; Device-Device Incompatibility

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). A 4.00 X 20 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING TREATMENT OF THE PROXIMAL CIRCUMFLEX, OTHER DEVICES SUCH AS THE IVUS CATHETER AND PRE-DILATION BALLOONS WERE ABLE TO CROSS THE LESION WITHOUT ISSUE. AFTER LESION PREPARATION, THE AGENT BALLOON COULD NOT BE CROSS LESION AND REPEATED ATTEMPTS TO DELIVER IT CAUSED THE GUIDE CATHETER TO BACK OUT OF THE CORONARY ARTERY MULTIPLE TIMES. THE HYPOTUBE BECAME BENT AND SHOWED A SLIGHT SHAFT FRACTURE, THOUGH THE DEVICE WAS REMOVED INTACT. THE PROCEDURE SUCCESSFULLY COMPLETED WITH A 4.00 X 16MM SYNERGY STENT. NO PATIENT COMPLICATIONS OCCURRED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474528 ↗
• MalfunctionFeb 18, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 4.00 MM X 20.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR TREATMENT ON A OF THE PROXIMAL CIRCUMFLEX. DURING THE PROCEDURE, WHILE ADVANCING ACROSS THE LESION, THE SHAFT BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRUG COATED BALLOON. THERE WAS NO PATIENT COMPLICATION, AND THE PATIENT FULLY RECOVERED AND WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378548 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPPER CHEST DISCOMFORT, PRURITUS AND RASH OCCURRED. A 4.00 X 20 MM AGENT DRUG-COATED BALLOON (DCB) WAS USED IN THE PATIENT'S SAPHENOUS VEIN GRAFT. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED AN UPPER CHEST RASH WITH ASSOCIATED PRURITUS. THE PHYSICIAN PRESCRIBED ANTIHISTAMINES (ZYRTEC) AND A BETA BLOCKER TO MANAGE THE SYMPTOMS; HOWEVER, THE PATIENT HAS CONTINUED TO EXPERIENCE DISCOMFORT SINCE (B)(6) 2025.

  Patient problems: Discomfort; Itching Sensation; Rash

  MAUDE report 23805223 ↗