AGENT™ H7493960820250Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00191506014803), received between Jun 20, 2025 and Sep 1, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 6 most recent of 6 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 elevated cardiac enzymes and myocardial infarction occurred. The patient was on a prior regimen of antiplatelet other than Aspirin (>= 72 hours). At the time of the procedure, Heparin or other antithrombotic medication and a loading dose of 325 mg of Aspirin and 300 mg of Clopidogrel were given. The 3.0 mm x 33 mm target lesion located at the distal circumflex (CX) vessel in the main branch was pretreated with 3.0 mm x 15 mm non-compliant balloon angioplasty catheter resulting in 0% residual stenosis and TIMI flow 3. The lesion was then successfully treated with 3.0 mm x 33 mm drug eluting stent (non-Boston Scientific device) achieving 0% residual stenosis with TIMI flow 3. The other 2.5 mm x 15 mm target lesion located at the 2nd obtuse marginal vessel in the side branch was pretreated with a 2.5 mm x 15 mm non-compliant balloon angioplasty catheter resulting in 0% residual stenosis and TIMI flow 3. The lesion was then successfully treated with the 2.5 mm x 20 mm AGENT DCB achieving 0% residual stenosis with TIMI flow 3. One day post procedure, the 18-24-hour post procedure lab draw demonstrated elevated levels of Troponin T HS and Troponin-I HS which met the

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction

  MAUDE report 50550330 ↗
• MalfunctionMar 31, 2026Material Rupture; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL, IN THE OBTUSE MARGINAL (OM) ARTERY. A 2.50 MM X 20.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS ADVANCED WITH RESISTANCE FOR TREATMENT. UPON INITIAL INFLATION OF THE BALLOON AT 6 ATM FOR LESS THAN 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746687 ↗
• MalfunctionFeb 27, 2026Break; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). A 2.50 MM X 20.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING DELIVERY, THE AGENT BALLOON WAS UNABLE TO CROSS THE LESION, AND THE HYPOTUBE BENT AND SUBSEQUENTLY FRACTURED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. A SECOND 3.00 MM X 30 MM AGENT DCB WAS THEN ADVANCED TO A MORE PROXIMAL SEGMENT, BUT THIS DEVICE ALSO FAILED TO CROSS THE LESION AND THE HYPOTUBE BECOME SIGNIFICANTLY BENT. IT WAS ALSO REMOVED WITHOUT INCIDENT. NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474527 ↗
• MalfunctionDec 16, 2025Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DEVICE BROKE OFF TOWARDS THE HUB. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS, MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE, A 2.50 MM X 20.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, WHILE ADVANCING THE BALLOON AND TRYING TO CROSS THE LESION, THE SHAFT BROKE OFF AND WAS KINKED TOWARDS THE HUB. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT COMPLICATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT 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 23821677 ↗
• MalfunctionSep 4, 2025Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS. A 2.50 X 20 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR USE. IT WAS NOTED THAT THE DEVICE APPEARED DIRTY UPON OPENING THE BOX. THE PROCEDURE SUCCESSFULLY COMPLETED WITH ANOTHER AGENT DCB. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965121 ↗
• InjuryJun 20, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT ISCHEMIA AND HYPOTENSION OCCURRED. A 2.50 X 20 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR USE. AGGRESSIVE PRE-DILATATION WAS PERFORMED FOR IN-STENT RESTENOSIS (ISR) AT THE OSTIAL CIRCUMFLEX, LEFT ANTERIOR DESCENDING ARTERY (LAD), AND LEFT MAIN BIFURCATION USING NC EMERGE AND NON-BOSTON SCIENTIFIC BALLOONS. THE DEVICE WAS PREPARED ACCORDING TO STANDARD PROTOCOL. DURING ATTEMPTED DELIVERY TO THE OSTIAL CIRCUMFLEX, THE AGENT BALLOON ENCOUNTERED RESISTANCE AND FAILED TO CROSS EASILY. MULTIPLE ATTEMPTS WITH DEEP GUIDE ENGAGEMENT LED TO ISCHEMIA. THE BALLOON WAS EVENTUALLY SUCCESSFULLY ADVANCED AND INFLATED; HOWEVER, AFTER 30 SECONDS OF INFLATION, THE PATIENT DEVELOPED SEVERE HYPOTENSION, REQUIRING ADMINISTRATION OF NEO-SYNEPHRINE (NEO), DEFLATION OF THE AGENT BALLOON, AND DISENGAGEMENT OF THE GUIDE CATHETER. FURTHER NEO-SYNEPHRINE WAS ADMINISTERED, AND THE PATIENT WAS INSTRUCTED TO COUGH TO MITIGATE THE RISK OF CARDIAC ARREST. AFTER 20 SECONDS, THE HYPOTENSION RESOLVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER COMPLICATIONS. THE PATIENT FULLY RECOVERED.

  Patient problems: Ischemia; Low Blood Pressure/ Hypotension

  MAUDE report 22299034 ↗