AGENT™ H7493960830250Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00191506014872), received between Jun 24, 2025 and Sep 1, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient complications occurred.The 10 mm x 2.50 mm target lesion was located in the mid left anterior descending artery (LAD). The patient was on a prior regimen of Aspirin (>= 72 hours) and antiplatelet other than Aspirin (>= 72 hours) at the time of index procedure. A loading dose of 325 mg of aspirin and 600 mg of clopidogrel were given prior to the procedure. The target lesion was pre-treated with four devices including a 2.50 mm x 12 mm non-compliant balloon angioplasty catheter resulting in 30% residual stenosis and TIMI flow 3. The target lesion was then successfully treated with a 2.50 mm x 30 mm Agent DCB resulting in 0% residual stenosis and TIMI flow of 3. Post-procedure, elevated cardiac enzymes were detected, and the patient was diagnosed with myocardial infarction. The patient was discharged from the hospital with the continuation of aspirin, and clopidogrel medication was started.

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction

  MAUDE report 50550390 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. AN AGENT DCB 2.50 X 30MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION WHICH WAS LOCATED IN THE MID TO DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LAD WAS PRE TREATED USING A WOLVERINE CUTTING BALLOON AND A SEMI COMPLIANT BALLOON ANGIOPLASTY CATHETER. THE LAD WAS THEN TREATED USING THE AGENT BALLOON, RESULTING IN 0% RESIDUAL STENOSIS AND TIMI FLOW OF 3. ONE DAY FOLLOWING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT EXPERIENCED A TEN TIMES INCREASE IN THE TROPONIN 1 HS LEVEL, WHICH MET THE CRITERIA OF MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 25681229 ↗
• MalfunctionMar 30, 2026Break; Difficult to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 2.50 MM X 30.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR TREATMENT OF THE MILDLY TO MODERATELY TORTUOUS POSTERIOR DESCENDING ARTERY (PDA). DURING THE PROCEDURE, DIFFICULTY WAS EXPERIENCED ADVANCING THE DEVICE TO THE INTENDED LOCATION. A GUIDE EXTENSION CATHETER WAS INTRODUCED AND THE SHAFT OF THE DEVICE BROKE DURING ADVANCEMENT. THE DEVICE WAS SNARED AND REMOVED FROM THE PATIENT. THE VESSEL WAS LEFT ALONE AND NOT TREATED WITH ANYTHING. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24737244 ↗
• MalfunctionFeb 27, 2026Inflation Problem

  IT WAS REPORTED THAT FAILURE TO INFLATE. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). A 2.50 X 30 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE BALLOON WAS DELIVERED BUT FAILED TO INFLATE; EVEN AFTER REMOVING IT FROM THE BODY, IT REMAINED NON-INFLATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE, WITH NO PATIENT COMPLICATIONS AND THE PATIENT FULL RECOVERED. HOWEVER, THE RETURN DEVICE ANALYSIS REVEALED A SHAFT TEAR IN THE POLYMER EXTRUSION AND LEAK OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474923 ↗
• MalfunctionDec 15, 2025Entrapment of Device; Nonstandard Device; Difficult to Advance; Entrapment of Device; Nonstandard Device; Difficult to Advance

  IT WAS REPORTED THAT THE DEVICE FROZE ON THE WIRE. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). THE TARGET LESION LOCATED IN THE CALCIFIED AND TORTUOUS CORONARY ARTERY. A 2.50 MM X 30.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING PROCEDURE, THE AGENT BECAME STUCK ON THE WIRE AND COULD NOT ADVANCE INTO THE BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810886 ↗
• MalfunctionDec 10, 2025Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE FROZE ON THE WIRE. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). A 2.50 MM X 30.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI), TARGETING AN IN-STENT RESTENOSIS (ISR) SEGMENT. DURING INSERTION, THE AGENT FAILED TO ADVANCE OVER THE GUIDEWIRE PRIOR TO ENTERING THE PATIENT. THE GUIDEWIRE WAS IN THE CORONARY ARTERY. UPON ATTEMPTED REMOVAL, IT BECAME STUCK AND REQUIRED EXTRACTION ALONG WITH THE WIRE AS A SINGLE UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER AGENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769763 ↗
• MalfunctionNov 18, 2025Break; Nonstandard Device; Difficult to Advance; Break; Nonstandard Device; Difficult to Advance

  IT WAS REPORTED THAT THE SHAFT BROKE. THE TARGET LESION, LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD), WAS PREPPED WITH AN NC EMERGE BALLOON. INTRAVASCULAR ULTRASOUND WAS NOT PERFORMED; HOWEVER, THE LAD WAS ASSUMED TO BE CALCIFIED AS DEVICES WERE DIFFICULT TO TRACK DOWN THE VESSEL. A 2.50 X 30 MM AGENT DCB WAS SELECTED FOR USE. WHEN THE DEVICE WAS CONNECTED TO THE INFLATION DEVICE, THE SHAFT SNAPPED OFF ABOUT 5 INCHES OUT FROM THE BACK CONNECTION END. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR TREATMENT OF THE COMPLEX LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587018 ↗
• MalfunctionAug 6, 2025Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 30MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. DURING PROCEDURE, AS THE BALLOON WAS BEING ADVANCED IT MET RESISTANCE. UPON FURTHER DELIVERING BALLOON THE SHAFT BENT AND FRACTURED. THE FRACTURED DISTAL END OF THE BALLOON WAS ABLE TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER AGENT DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728134 ↗
• MalfunctionJul 2, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURED. A 2.50 MM X 30.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR TREATMENT OF IN-STENT RESTENOSIS (ISR). DURING PROCEDURE, ON INFLATING, IT WAS NOTED THAT THE BALLOON RUPTURED AT 6ATM. THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE AND THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382506 ↗
• MalfunctionJun 24, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON DETACHED. A 2.50 MM X 30.00 MM AGENT (DBC) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PREPARATION, THE STYLET WAS TAKEN OUT, THE BALLOON SNAPPED. PROCEDURE WAS COMPLETED WITH NEW BALLOON AND NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318805 ↗