AGENT™ H7493960830300Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00191506014896), received between Aug 28, 2025 and Sep 30, 2026 — classified as 3 injuries, 5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a grade C dissection occurred. The 2.75 mm x 20 mm target lesion located at the 2nd diagonal branch was pretreated with two devices with the largest balloon size of 3 mm x 15 mm. The non-complaint balloon had a maximum inflation pressure of 8 and two balloon inflations. Final pretreatment stenosis was 40% with TIMI flow 3. IVUS with Opticross 6 catheter was used to confirmed pretreatment results. The target lesion was then successfully treated with a 3.0 mm x 30 mm Agent DCB device. The device achieved an inflation pressure of 6 with an inflation time of 80. However, a grade C dissection was discovered, and an interventional procedure was completed to place a non-Boston Scientific drug eluting stent. The patient was discharged.

  Patient problems: Vascular Dissection

  MAUDE report 50944990 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a NSTEMI requiring intervention occurred. In early (b)(6) 2026, the 2.75 mm x 25 mm target lesion located at the right posterior descending vessel was pretreated with a semi-compliant and non-compliant balloon with the largest balloon being 2.5 mm x 25 mm. Maximum inflation pressure was 16 with a total of 2 balloon inflations. Pretreatment resulted in 20% stenosis and TIMI flow 3. The target lesion was then successfully treated with a 3.0 mm x 30 mm AGENT DCB balloon, maximum inflation pressure was 8 with a total of 1 balloon inflation. Prior to the target lesion treatment, the non-target lesion located at the mid left anterior descending artery was also successfully treated with a 3.5 mm x 16 mm drug eluting stent and 3.75 mm x 12 mm balloon angioplasty catheter. Patient discharged on the same day of the procedure.Shortly after the procedure in (b)(6) 2026, the patient experienced dyspnea and had a NSTEMI that required an in-patient hospitalization, stent placement, target vessel revascularization and medication administration (Heparin). Patient discharged.It was later reported: That shortly after the procedure in (b)(6) 2026, the patient also experienced ches

  Patient problems: Chest Pain; Dyspnea; Myocardial Infarction; Restenosis; Vascular Dissection

  MAUDE report 50619349 ↗
• InjuryJul 8, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE BALLOON FAILED TO EXIT THE GUIDE CATHETER REQUIRING ADDITIONAL INTERVENTION. AN AGENT (DCB) WAS SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION IN THE EXAMINATION OF THE RIGHT CORONARY ARTERY. DURING THE PROCEDURE THE LESION WAS PRETREATED WITH BALLOONS AND THEN A SYNERGY XD STENT WAS IMPLANTED. THE AGENT DCB WAS ATTEMPTED BUT WOULD BARLEY COME OUT OF THE GUIDE CATHETER AND A GUIDEZILLA WAS NEEDED TO REMOVE IT. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25749333 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 3.00 MM X 30 MM AGENT DCB WAS SELECTED FOR USE. HOWEVER, THE BALLOON SHAFT BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968979 ↗
• MalfunctionApr 6, 2026Break; Nonstandard Device; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE IN-STENT RESTENOSED TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. FOLLOWING LESION PREPARATION, THE 3.00 MM X 30.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS INTRODUCED. DURING THE DELIVERY PROCESS, RESISTANCE WAS ENCOUNTERED PROXIMAL TO THE LESION AND THE BALLOON SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A SHORTER AGENT DCB. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793877 ↗
• MalfunctionNov 17, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. A 3.00 MM X 30.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING PROCEDURE, AFTER INFLATION, THE BALLON FELT STICKY DURING WITHDRAWAL AND TIGHTNESS WAS EXPERIENCED DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AND THE DEVICE WAS ABLE TO BE REMOVED. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569755 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). A 3.00 X 30MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). IT WAS NOTED THAT THE DELIVERY SHAFT BROKE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316983 ↗
• MalfunctionAug 28, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON HAD A HOLE. THE 60% STENOSED LESION WAS LOCATED IN A MILDLY TORTUOUS LESION. A 3.00 MM X 30.00 MM AGENT DRUG-COATED BALLOON (DCB) WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI), ALONG WITH VEIN GRAFT ANASTOMOSIS, TO TREAT IN-STENT RESTENOSIS (ISR). 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 PREPARED AND ADVANCED OVER THE GUIDEWIRE; HOWEVER, IT FAILED TO MAINTAIN PRESSURE DURING INFLATION DUE TO A HOLE IN THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER BALLOON AND THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916488 ↗