ENGAGE™ C408507Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05414734030465), received between Nov 27, 2019 and Jun 28, 2024 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2024Material Separation; Material Separation

  AT THE END OF A DIAGNOSTIC CATHETERIZATION PROCEDURE, WHILE ATTEMPTING ROUTINE SHEATH REMOVAL FROM THE RIGHT FEMORAL ARTERY, THE DEVICE SEPARATED INTO TWO PIECES. THE SHEATH BROKE APART JUST UNDER THE HEMOSTATIC VALVE OF THE SHEATH RESULTING IN SIGNIFICANT BLEEDING. PRESSURE WAS APPLIED AND A HEMOSTAT WAS APPLIED TO THE EXPOSED SHEATH PIECE. UPON THE PHYSICIAN'S ARRIVAL THE PATIENT WAS AWAKE AND TALKING BUT MILDLY HYPOTENSIVE. WHILE MAINTAINING HEMOSTASIS WITH DIRECT PRESSURE, THE REMAINDER OF THE SHEATH WAS REMOVED FROM THE ARTERIOTOMY UNEVENTFULLY. MANUAL PRESSURE WAS APPLIED TO THE ARTERIOTOMY AS USUAL.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19638913 ↗
• MalfunctionJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A CORONARY ANGIOGRAM PROCEDURE, THERE WAS LEAKING NOTED WHILE USING AN ENGAGE INTRODUCER. THE PHYSICIAN STATED THAT IT DOES NOT HAPPEN WITH EVERY INTRODUCER BUT ESTIMATES ABOUT EVERY 1 IN 5-8 CASES THERE IS LEAKING NOTED. IT WAS CONFIRMED THAT NO LEAKING WAS NOTED PRIOR TO CATHETER USE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. THERE HAVE BEEN ADDITIONAL COMPLAINTS ABOUT ENGAGE 6F INTRODUCERS LEAKING DURING CASES. THE LEAKING HAS NOT OCCURRED WITH EVERY INTRODUCER USED; HOWEVER, 3 CARDIOLOGISTS HAVE EXPERIENCED THIS ISSUE. LEAKING OCCURRED WITH 4 INTRODUCERS USED LAST WEEK. IT IS UNKNOWN IF THE ISSUE IS WITH THIS SPECIFIC LOT OR NOT. THE LAST 4 UNOPENED INTRODUCERS WITH LOT NUMBER 8846300 WERE OBTAINED TO RETURNED FOR INVESTIGATION. ALL PROCEDURES WERE COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES BY EXCHANGING THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556038 ↗
• MalfunctionJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A CORONARY ANGIOGRAM PROCEDURE, THERE WAS LEAKING NOTED WHILE USING AN ENGAGE INTRODUCER. THE PHYSICIAN STATED THAT IT DOES NOT HAPPEN WITH EVERY INTRODUCER BUT ESTIMATES ABOUT EVERY 1 IN 5-8 CASES THERE IS LEAKING NOTED. IT WAS CONFIRMED THAT NO LEAKING WAS NOTED PRIOR TO CATHETER USE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. THERE HAVE BEEN ADDITIONAL COMPLAINTS ABOUT ENGAGE 6F INTRODUCERS LEAKING DURING CASES. THE LEAKING HAS NOT OCCURRED WITH EVERY INTRODUCER USED; HOWEVER, 3 CARDIOLOGISTS HAVE EXPERIENCED THIS ISSUE. LEAKING OCCURRED WITH 4 INTRODUCERS USED LAST WEEK. IT IS UNKNOWN IF THE ISSUE IS WITH THIS SPECIFIC LOT OR NOT. THE LAST 4 UNOPENED INTRODUCERS WITH LOT NUMBER 8846300 WERE OBTAINED TO RETURNED FOR INVESTIGATION. ALL PROCEDURES WERE COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES BY EXCHANGING THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19555992 ↗
• MalfunctionApr 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE DIAGNOSTIC PROCEDURE, AFTER INSERTING THE CATHETER, A BLOOD LEAK WAS NOTED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072310 ↗
• MalfunctionApr 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE DIAGNOSTIC PROCEDURE, AFTER INSERTING THE CATHETER, A BLOOD LEAK WAS NOTED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072296 ↗
• MalfunctionMar 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ANGIOGRAM PROCEDURE THE SHEATH WAS LEAKING BLOOD THROUGH THE VALVE. BLOOD WAS WIPED AWAY AS NEEDED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980552 ↗
• MalfunctionFeb 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  CORRECTED PMA/510K NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684265 ↗
• MalfunctionFeb 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A BLOOD LEAK OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634266 ↗
• MalfunctionJan 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A BLOOD LEAK OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595160 ↗
• MalfunctionDec 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE IT WAS NOTED THAT WHEN THE MICROCATHETER WAS PULLED OUT OF THE SHEATH, IT WAS NOT CLOSING AT ALL, ALLOWING BLOOD OUT. IT WAS NECESSARY TO APPLY PRESSURE TO THE GROIN AND REPLACE THE SHEATH. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378949 ↗
• MalfunctionDec 21, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS NOTED THAT WHEN THE MICROCATHETER WAS REMOVED FROM THE SHEATH, IT WAS UNABLE TO CLOSE. IT WAS NOTED TO BE A CLINICALLY SIGNIFICANT DELAY. NO OTHER INFORMATION IS AVAILABLE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18372158 ↗
• MalfunctionNov 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURE REF: 3005334138-2023-00534. DURING A DIAGNOSTIC CARDIAC CATH PROCEDURE, UPON REMOVAL OF THE DEVICE FROM THE PATIENT, BLOOD WAS NOTED INSIDE THE DEVICE DUE TO A VALVE ISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140527 ↗
• MalfunctionOct 23, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  POST PROCEDURE, A SIDEPORT DETACHMENT OCCURRED. THE INTRODUCER WAS INSERTED INTO THE PATIENT AT (B)(6) AND ARRIVED AT (B)(6) A FEW DAYS LATER. WHEN EXCHANGING THE PRESSURE SET, THE TUBE OF THE INTRODUCER DETACHED AND BLEEDING OCCURRED. THE BLEEDING STOPPED FOLLOWING REMOVAL OF THE INTRODUCER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17985495 ↗
• MalfunctionSep 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURING REFERENCE: 3005334138-2023-00433 DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BLOOD LEAK OCCURRED. THE DEVICE WAS EXCHANGED WITH ANOTHER INTRODUCER FROM THE SAME LOT, AND THE SAME ISSUE OCCURRED. THE SHEATH WAS REPLACED WITH AN 8F SHEATH AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17793735 ↗
• MalfunctionSep 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURING REFERENCE: 3005334138-2023-00434 DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BLOOD LEAK OCCURRED. THE DEVICE WAS EXCHANGED WITH ANOTHER INTRODUCER FROM THE SAME LOT, AND THE SAME ISSUE OCCURRED. THE SHEATH WAS REPLACED WITH AN 8F SHEATH AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17793693 ↗
• MalfunctionDec 4, 2022Material Separation; Material Separation

  DURING THE PERIPHERAL ANGIOGRAM PROCEDURE, IT WAS NOTED THAT THE SHEATH SEPARATED FROM THE HUB WHILE IT WAS BEING REMOVED FROM THE PATIENT. NO INTERVENTIONS WERE REQUIRED TO REMOVE THE SHEATH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15912719 ↗
• InjuryNov 24, 2020Material Separation; Material Separation

  DURING AN EKOS PROCEDURE, WHILE INSERTING THE EKOS CATHETER, HALF OF THE ENGAGE SHEATH BROKE OFF WHILE INSIDE THE PATIENT AND MADE ITS WAY TO THE RV WHICH REQUIRED EMERGENCY SURGERY. ALL PIECES WERE SUCCESSFULLY REMOVED AND THE PATIENT IS IN STABLE CONDITION. THE HOSPITAL WILL NOT BE RETURNING THE DEVICE.

  Patient problems: Embolism

  MAUDE report 10894973 ↗
• MalfunctionNov 27, 2019Material Separation; Material Separation

  WHILE REMOVING THE DEVICE FROM THE RIGHT RADIAL ARTERY, THE HUB OF THE SHEATH DETACHED. THE SHEATH WAS PULLED FROM THE PATIENT'S ANATOMY WITHOUT ANY INTERVENTION. THE PROCEDURE WAS COMPLETED WITH MANUAL COMPRESSION AND A HEMO BAND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9382940 ↗