ENGAGERecalls & reported problems across all models

We found 11 models of ENGAGE by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Jul 9, 2018 and Jun 10, 2025 — classified as 5 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (27 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 ENGAGE problems

ENGAGE models

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

• ENGAGE™ C408507

  INTRODUCER, CATHETER
  18 reports
• ENGAGE™ C408536

  INTRODUCER, CATHETER
  10 reports
• ENGAGE™ C408508

  INTRODUCER, CATHETER
  6 reports
• ENGAGE™ C408509

  INTRODUCER, CATHETER
  3 reports
• ENGAGE™ C408527

  INTRODUCER, CATHETER
  3 reports
• ENGAGE™ C408506

  INTRODUCER, CATHETER
  2 reports
• ENGAGE™ C408539

  INTRODUCER, CATHETER
  1 report
• ENGAGE™ C408501

  INTRODUCER, CATHETER
  1 report
• ENGAGE™ C408502

  INTRODUCER, CATHETER
  1 report
• ENGAGE™ C408503

  INTRODUCER, CATHETER
  1 report
• ENGAGE™ C408504

  INTRODUCER, CATHETER
  1 report

Recent ENGAGE adverse event reports

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

• InjuryJun 10, 2025Material Separation; Material Separation

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH SEPARATED INTO TWO PIECES. ONE HALF OF THE SHEATH WAS ABLE TO BE REMOVED FROM THE PATIENT, BUT THE OTHER HALF OF THE SHEATH REQUIRED A SNARE FOR REMOVAL. IMAGING WAS USED TO ACCOUNT FOR ALL PIECES. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22179130 ↗
• MalfunctionMay 8, 2025Material Separation; Material Separation

  ON (B)(6) 2025 THE PATIENT UNDERWENT A SUCCESSFUL EMBOLIZATION OF THE RIGHT BRONCHIAL ARTERY IN THE CONTEXT OF LUNG BLEEDING AT INTERVENTIONAL RADIOLOGY. ON (B)(6) 2025, DURING THE REMOVAL OF A FEMORAL ARTERIAL SHEATH USING FEMOSTOP IN THE INTENSIVE CARE UNIT, A PIECE OF THE CATHETER BROKE OFF. A CT ANGIOGRAM CONFIRMED THAT A PIECE OF THE CATHETER REMAINED AT THE LEVEL OF THE COMMON FEMORAL ARTERY WITHOUT IMPACT ON BLOOD FLOW. IN CONSULTATION WITH VASCULAR SURGERY, THIS PIECE WAS SURGICALLY REMOVED UNDER LOCAL ANESTHESIA ON (B)(6) 2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 21987684 ↗
• MalfunctionNov 26, 2024Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  DURING A REDO TYPICAL FLUTTER PROCEDURE, THE ADVISOR HD GRID BECAME ENTANGLED IN THE PATIENT ANATOMY REQUIRING SURGICAL REMOVAL OF THE DEVICE. AFTER POSITIONING THE CORONARY SINUS CATHETER, THE ADVISOR HD GRID CATHETER WAS PLACED INSIDE THE PATIENT AND MAPPING BEGAN IN THE RIGHT ATRIUM. THE CATHETER WAS DIFFICULT TO MANEUVER, BECAME STUCK, AND ATTEMPTS TO REMOVE THE CATHETER FROM THE ENGAGE INTRODUCER WERE UNSUCCESSFUL. IT WAS THEN ATTEMPTED TO REMOVE BOTH THE CATHETER AND INTRODUCER TOGETHER, HOWEVER ONLY THE INTRODUCER CAME OUT. DAMAGE WAS THEN NOTED ON THE INTRODUCER. ANOTHER INTRODUCER WAS USED, AND THE CATHETER WAS CUT IN HALF IN AN ATTEMPT TO REMOVE IT, HOWEVER IT WAS UNSUCCESSFUL. A VASCULAR SURGEON WAS THEN CALLED IN AND REMOVED THE INTRODUCER THAT WAS USED FOR THE CORONARY SINUS CATHETER AND THE NEW INTRODUCER THAT WAS USED TO TRY TO GET THE CATHETER OUT. THIS ALLOWED THE CATHETER TO BE REMOVED. UPON REMOVAL, A RED STRUCTURE ALLEGED TO BE A CLOT, OR A SMALL PART OF THE VEIN COULD BE SEEN. THE PROCEDURE WAS THEN STOPPED WITH NO FURTHER COMPLICATIONS. PER THE ADVISOR HD GRID CATHETER INSTRUCTIONS FOR USE, AN 8.5F MINIMUM INTRODUCER SHOULD BE USED. THE ENGAGE INTRODUCER USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787140 ↗
• MalfunctionOct 4, 2024Material Separation; Material Separation

  AFTER THE COMPUTED TOMOGRAPHY CORONARY ANGIOGRAPHY PROCEDURE, WHEN ATTEMPTING TO REMOVE INTRODUCER, THE HUB AND SIDEPORT DETACHED. THEY MANAGED TO GET IT INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372563 ↗
• 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 29, 2024Material Separation; Material Separation

  DURING THE PROCEDURE, THE SHAFT OF THE SHEATH DETACHED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19002741 ↗
• 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 ↗
• MalfunctionMar 19, 2024Material Separation; Material Separation

  DURING THE PROCEDURE, THE SHAFT OF THE SHEATH DETACHED. THE SHEATH WAS PLACED IN FEMORAL ARTERY FOR A DIAGNOSTIC HEART CATHETERIZATION PROCEDURE. ONCE IT TURNED INTO AN INTERVENTION, THE SHEATH HAS TO BE UP SIZED TO A 6F. A J-WIRE WAS INTRODUCED THRU THE 5F SHEATH AND IN AN ATTEMPT TO REMOVE IT, THE HUB SEPARATED FROM THE SHAFT. THE SHAFT WAS PARTIALLY OUTSIDE THE PATIENT AND WAS REMOVED BY SLIDING IT OVER THE WIRE. A 6F SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18932956 ↗
• 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 ↗

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