AGENTRecalls & reported problems across all models

We found 23 models of AGENT by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 86 adverse event reports in the FDA's MAUDE database, received between Aug 15, 2024 and Sep 30, 2026 — classified as 13 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Break” (39 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AGENT problems

AGENT models

23 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AGENT™ H7493960830250

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  10 reports
• AGENT™ H7493960820300

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  8 reports
• AGENT™ H7493960830300

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  8 reports
• AGENT™ H7493960820250

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  6 reports
• AGENT™ H7493960830400

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  6 reports
• AGENT™ H7493960815300

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  5 reports
• AGENT™ H7493960820400

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  5 reports
• AGENT™ H7493960830350

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  5 reports
• AGENT™ H7493960812300

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  4 reports
• AGENT™ H7493960815250

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  4 reports
• AGENT™ H7493960820350

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  4 reports
• AGENT™ H7493960815350

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  3 reports
• AGENT™ H7493960815400

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  3 reports
• AGENT™ H7493960820220

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  3 reports
• AGENT™ H7493960812250

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  2 reports
• AGENT™ H7493960812350

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  2 reports
• AGENT™ H7493960830270

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  2 reports
• AGENT™ H7493960812400

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  1 report
• AGENT™ H7493960815200

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  1 report
• AGENT™ H7493960815270

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  1 report
• AGENT™ H7493960820200

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  1 report
• AGENT™ H7493960830200

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  1 report
• AGENT™ H7493960830220

  Drug-eluting percutaneous transluminal coronary angioplasty catheter
  1 report

Recent AGENT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

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

  Patient problems: Vascular Dissection

  MAUDE report 50948445 ↗
• 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 ↗
• MalfunctionSep 26, 2026Break; Deformation Due to Compressive Stress; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50909432 ↗
• MalfunctionSep 9, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697637 ↗
• MalfunctionSep 8, 2026Contamination; Packaging Problem

  It was reported that device contamination occurred.Upon arrival to the facility, a 2.00 x 15mm Agent DCB was discovered to have damage to the outer box and the inner packaging was ripped open, compromising the sterility of the device. The shipping box was also noted to be damaged as well. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674697 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 19, 2026Break; Difficult to Advance

  It was reported that a shaft break occurred.The 90% stenosed target lesion was located in a moderately tortuous and severely calcified distal right coronary artery (RCA). A 4.00 mm x 15.00 mm Agent drug coated balloon (DCB) was selected for treatment. During the procedure, while the physician was advancing the balloon, it snapped at the mid shaft. The device was removed as a single unit, and the procedure was completed using a different device.It was further reported that the user encounter resistance while advancing the device. It was fractured on the balloon shaft. And there was no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334625 ↗
• MalfunctionAug 19, 2026Break; Failure to Advance

  It was reported that a shaft break within a patient occurred. A 3.00 mm x 12mm AGENT US MR was selected for a Percutaneous Coronary Intervention to evaluate the target lesion. During the procedure, the device could not advance in the lesion and the shaft subsequently broke. The procedure was completed as planned and the device was successfully removed in one piece from the patient. No patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334624 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Vascular Dissection

  MAUDE report 50229874 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient complications occurred.A loading dose of 324 mg of aspirin and 600 mg of clopidogrel were given prior to the procedure. The 8.00 mm x 2.50 mm target lesion was located in the first diagonal branch of the left anterior descending artery (LAD). The target lesion was pre-treated with a 2.50 mm x 15 mm non-compliant balloon angioplasty catheter resulting in 10% residual stenosis and TIMI flow 3. The target lesion was then successfully treated with a 2.50 mm x 15 mm Agent DCB resulting in 0% residual stenosis and TIMI flow of 3. An additional 28 mm x 3.00 mm target lesion located from the proximal to mid LAD was pre-treated with a 2.50 x 15 mm semi-compliant balloon angioplasty catheter resulting in 30% residual stenosis and TIMI flow of 3. The lesion was further treated with a 3.00 mm x 33 mm non-Boston Scientific drug eluting stent resulting in 0% residual stenosis and TIMI flow of 3. A non-target lesion located in the mid right coronary artery (RCA) was successfully treated prior to the treatment of target lesion using a 4.00 mm x 28 mm drug eluting stent and a 4.00 mm x 15 mm balloon angioplasty catheter. Post-procedure, elevated cardiac enzymes were det

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction

  MAUDE report 50073432 ↗
• MalfunctionJul 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071001 ↗
• 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 ↗
• 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 ↗

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