AGENT™ H7493960820300Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00191506014827), received between Mar 24, 2025 and Aug 12, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Vascular Dissection

  MAUDE report 50229874 ↗
• MalfunctionJun 8, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 20MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING PROCEDURE, WHILE TRYING TO DELIVER BALLOON, THE SHAFT BROKE. PHYSICIAN WAS ABLE TO RETRIEVE BROKEN SHAFT FROM GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429747 ↗
• MalfunctionApr 17, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26MARCH2026. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO CROSS. THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS (ISR) FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI). A 3.00 MM X 20.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR USE. FOLLOWING PRE-TREATMENT WITH BALLOON ANGIOPLASTY AND CONFIRMED WITH INTRAVASCULAR ULTRASOUND, THE AGENT DCB WAS INSERTED BUT WAS UNABLE TO CROSS THE TARGET LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED. HOWEVER, THE RETURN DEVICE ANALYSIS REVEALED A TEAR WAS NOTED TO THE OUTER SHAFT POLYMER EXTRUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913672 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT THE SHAFT BROKE. AN AGENT US MR 3.00 X 20MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. DURING THE PROCEDURE WHILE INSIDE THE GUIDE CATHETER, THE AGENT BALLOON SHAFT BROKE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650604 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 3.00 MM X 20.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, WHILE INSERTING THE BALLOON THE SHAFT BROKE. THE DEVICE WAS REMOVED FROM PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATIVE 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 23865385 ↗
• MalfunctionAug 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED. THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS (ISR) FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI). A 3.00 MM X 20.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS USED AT THE RIGHT CORONARY ARTERY (RCA). VESSEL PREPARATION WAS INITIATED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA) USING AN EMERGE BALLOON, FOLLOWED BY INTRAVASCULAR LITHOTRIPSY (IVL). THE AGENT DEVICE WAS FOUND TO BE UNDAMAGED DURING UNPACKING AND PREPARATION FOR USE, AND IT ADVANCED SMOOTHLY OVER THE WIRE AND THROUGH THE GUIDEWIRE WITHOUT ANY DIFFICULTY. THE AGENT DCB WAS ADVANCED; HOWEVER, THE BALLOON RUPTURED AT 6 ATM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER AGENT DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED, AND THE PATIENT WAS DOING WELL POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701416 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BROKE. A 3.00 X 20MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR USE. DURING PROCEDURE, SHAFT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169737 ↗
• MalfunctionMar 24, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE SHAFT SEPARATION OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD). A 3.00 X 20MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR LEFT HEART CATHETERIZATION (LHC). THE TARGET LESION PROPERLY PREPARED WITH NON-BOSTON SCIENTIFIC INTRAVASCULAR LITHOTRIPSY (IVL) AND INTRAVASCULAR ULTRASOUND (IVUS). WHEN THE CATHETER WAS ADVANCED AND POSITIONED PROXIMAL TO THE LESION, THE CATHETER UNABLE TO CROSS THE LESION, AND THE SHAFT BROKE. THE PHYSICIAN WAS REMOVED THE DEVICE IN ONE PIECE WITHOUT ANY PROBLEMS. THE PROCEDURE COMPLETED WITH ANOTHER AGENT DCB AND THERE WAS NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677962 ↗