AGENT™ H7493960830400Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00191506014919), received between Jan 8, 2025 and Jul 9, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Nonstandard Device; Material Rupture

  It was reported that a balloon rupture occurred.A 4.00 mm x 30.00 mm Agent drug-coated balloon (DCB) was selected for an in-stent restenosis (ISR) treatment. The balloon ruptured immediately upon launch without inflation. The guide catheter was also positioned within the vessel at the time of the event. The device was removed from patient; the procedure was successfully completed with an alternative device. There was no patient complication reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25774276 ↗
• MalfunctionMay 15, 2026Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION LOCATED WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). A 4.00 MM X 30 MM AGENT DCB WAS SELECTED FOR USE AND ADVANCED TO THE LESION SITE. DURING THE FIRST INFLATION AT 12 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING TWO SEPARATE 4.00 MM X 15 MM AGENT DCB BALLOONS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186906 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 4.00 X 30MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, THE SHAFT BROKE. ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS REMOVED FROM THE PATIENT; THERE WAS NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926596 ↗
• InjuryOct 10, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLON DETACHED. THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS (ISR). THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 4.00 MM X 30.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). NO DAMAGE WAS OBSERVED DURING DEVICE UNPACKING OR PREPARATION, AND THE DEVICE ADVANCED SMOOTHLY OVER THE WIRE AND THROUGH THE GUIDE CATHETER WITHOUT DIFFICULTY. THE BALLOON WAS INFLATED ONCE AT NORMAL PRESSURE FOR 60 SECONDS. DURING DEVICE WITHDRAWAL, THE BALLOON DETACHED FROM THE SHAFT AND BECAME STUCK WITHIN A NON-BOSTON SCIENTIFIC GUIDING CATHETER. THE DISLODGED BALLOON WAS SUCCESSFULLY REMOVED USING HEMOSTATS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23267291 ↗
• MalfunctionMar 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE 4.00 X 30MM AGENT DCB WAS INTRODUCED TO TREAT THE TARGET LESION BUT THE BALLOON MATERIAL RUPTURED. THE PROCEDURE WAS COMPLETED WITH A BALLOON ANGIOPLASTY CATHETER RESULTING IN 25% RESIDUAL STENOSIS AND TIMI 3 FLOW. IT WAS ADDITIONALLY REPORTED THAT THE TARGET LESION WAS 50% STENOSED, AND THE AGENT DCB WAS INFLATED TO 14 ATM FOR 25 TO 30 SECONDS WHEN IT RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700336 ↗
• MalfunctionJan 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. AN AGENT US MR 4.00 X 30MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION, WHICH WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE, THE PHYSICIAN INFLATED THE BALLOON TO 11ATM WHEN A LOSS OF PRESSURE WAS NOTED IN THE INFLATION DEVICE. THE DEVICE WAS PULLED, AND THE BALLOON WAS NOTED TO HAVE RUPTURED. THE BALLOON WAS REMOVED FROM THE PATIENT AND ANOTHER SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105117 ↗