ENGAGE™ C408536Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05414734030403), received between Sep 21, 2018 and Oct 17, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE BALLOON WAS INSERTED INTO THE PATIENT AND FILLED WHEN A BLOOD LEAK WAS NOTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951083 ↗
• MalfunctionOct 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE BALLOON WAS INSERTED INTO THE PATIENT AND FILLED WHEN A BLOOD LEAK WAS NOTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950693 ↗
• MalfunctionOct 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE BALLOON WAS INSERTED INTO THE PATIENT AND FILLED WHEN A BLOOD LEAK WAS NOTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950270 ↗
• MalfunctionOct 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE BALLOON WAS INSERTED INTO THE PATIENT AND FILLED WHEN A BLOOD LEAK WAS NOTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950206 ↗
• MalfunctionOct 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE BALLOON WAS INSERTED INTO THE PATIENT AND FILLED WHEN A BLOOD LEAK WAS NOTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950138 ↗
• MalfunctionAug 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BLOOD LEAK OCCURRED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542280 ↗
• MalfunctionAug 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BLOOD LEAK OCCURRED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542267 ↗
• MalfunctionAug 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BLOOD LEAK OCCURRED. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468896 ↗
• MalfunctionJul 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BLOOD LEAK OCCURRED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415519 ↗
• MalfunctionSep 21, 2018Fracture; Fracture

  THE ENGAGE TR INTRODUCER WAS USED IN PROCEDURE AND FRACTURED NEAR THE PROXIMAL BASE OF THE DEVICE WHEN ATTEMPTING TO INSERT INTO THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION IS EXPECTED. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7900183 ↗