THRUPORT SYSTEMS INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE ICF100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00690103190007), received between Apr 15, 2021 and Aug 13, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K132175, K163693); they may or may not involve this specific model.

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 18, 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.

• InjuryAug 13, 2025Use of Device Problem; Use of Device Problem

  EDWARDS RECEIVED A REPORT OF AN AORTIC DISSECTION DURING AN MVR CASE WHERE THE SURGEON WAS PLANNING ON USING THE ICF100 TO OCCLUDE THE AORTA. THE GUIDEWIRE FROM THE ICF100 KIT MET RESISTANCE WHILE PLACING THE ICF100. THEY PULLED THE WIRE BACK AND TRIED AGAIN AND FELT RESISTANCE. THE WIRE WAS TAKEN OUT AND KINKS WERE FOUND. THE SURGEON DECIDED WITH THE REP TO TRY A NEW WIRE FROM ANOTHER ICF100 KIT. THE ENDORETURN WAS ADJUSTED PRIOR TO TRYING TO REINSERT ICF100 AND GUIDEWIRE. NO RESISTANCE DURING INSERTION. BYPASS INITIATED SLOWLY AND NO DISSECTION WAS SEEN AT THAT TIME. ANOTHER DOCTOR ARRIVED AND WANTED ER21B TO BE ADVANCED A LITTLE AND ADVANCED 1-2CM AND RESECURED. AORTIC ROOT PRESSURE WAS LOST AND THE CLINICAL REP ADVISED TO GET ASCENDING AORTA TEE VIEW AND BALLOON WAS AGAINST THE AORTIC VALVE. REP ADVISED TO PULL BACK BALLOON TO PA LEVEL ON TEE. ROOT PRESSURE RETURNED. ROBOT WAS THEN DOCKED BY OR STAFF. AFTER DOCKING DR. (B)(6) LOOKED INTO RIGHT CHEST INCISION AND ASKED FOR ASCENDING AORTA TEE VIEW (15 MINUTES HAVE PASSED SINCE BYPASS INITIATION). ANESTHESIA VISUALIZED WHAT SHE THOUGHT WAS THE BALLOON INFLATED, BUT THE BALLOON WAS NOT YET INFLATED. IN TEE THE ASCENDING AORTA WAS

  Patient problems: Aortic dissection

  MAUDE report 22790945 ↗
• MalfunctionJul 2, 2025Use of Device Problem; Use of Device Problem

  EDWARDS RECEIVED A REPORT OF A CASE WHERE THREE ICF100'S WERE OPENED IN ORDER TO COMPLETE THE CASE SUCCESSFULLY. THE FIRST HAD POTENTIAL PRESSURE READING ISSUES AND POTENTIALLY RUPTURED/ LEAKED. THE SECOND HAD CLAMP LOCK/ MIGRATION ISSUES. THE THIRD WAS USED SUCCESSFULLY. THE FIRST ICF100 USED IN THE CASE IS AVAILABLE FOR RETURN. THE SECOND DEVICE WAS DISCARDED BUT BELIEVED TO BE FROM THE SAME LOT. THERE WAS REPORTEDLY NO PATIENT IMPACT DUE TO THE EVENT(S). THERE WAS PROCEDURAL DELAY AND CONCERN REPORTED. IT WAS REPORTED THAT THE PATIENT IS OKAY AND THE PROCEDURE WAS SUCCESSFUL. A RESPONSE IS REQUESTED. THIS COMPLAINT INVESTIGATION IS FOCUSED ON THE FIRST DEVICE THAT MALFUNCTIONED. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE: NO ECV/ EDWARDS REPRESENTATIVE WAS PRESENT DURING THE CASE. NO ABNORMALITY WAS NOTED DURING DEVICE PREPARATION. PRESSURE READING WAS ZERO AND THERE WAS NO PRESSURE AT ONE POINT ON THE DEVICE WITH POTENTIAL PRESSURE ISSUES. ICF100 DEVICE WHICH WAS SUCCESSFUL WAS FROM THE SAME LOT. PRESSURES ARE AVAILABLE IN THE CASE NOTES. THE PATIENT DID HAVE AN "ALMOST TORTUOUS ARCH; THE CURVATURE WAS STEEP." REP MENTIONED POTENTIAL CALCIFICATION AND A TIGHT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386757 ↗
• MalfunctionMay 21, 2025Difficult to Flush

  INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE WOULD NOT FLUSH CARDIOPLEGIA. MANUFACTURER RESPONSE FOR INTRA AORTIC OCCLUSION DEVICE, EDWARDS (PER SITE REPORTER). INCIDENT REPORTED TO VENDOR BY HOSPITAL'S QUALITY TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059387 ↗
• MalfunctionApr 2, 2025Mechanical Problem; Mechanical Problem

  EDWARDS RECEIVED A REPORT ABOUT AN INTRACLUDE (ICF100) BALLOON LEAK DURING A ROBOTIC MVR CASE. AFTER OCCLUDING AORTA AND ARRESTING HEART, SURGEON NOTED LOSS OF OCCLUSION AFTER ABOUT 15MIN. PARAMETERS ALL NORMAL RANGES OF BALLOON PRESSURES AND EXPECTED INITIAL VOLUME (AROUND 24CC FOR INITIAL OCCLUSION) BASED ON SIZE OF AORTA (3.2 CM). SURGEON ADDED MORE VOLUME (A FEW CC'S EACH TIME) TO ICF100 TO OCCLUDE THE AORTA AND REACH AN INTERNAL PRESSURE OF AROUND 400MMHG. THIS HAPPENED 2 MORE TIMES. DURING THE PROCEDURE, THERE WAS A NORMAL LEVEL OF TUGGING/ PULLING DURING PLACEMENT. NO ABNORMAL RESISTANCE WHEN REMOVING THE DEVICE. SURGERY COMPLETE WITH NO ADVERSE EVENTS. UPON COMPLETION OF CASE, SURGEON FILLED THE BALLOON WITH SALINE ON BACK TABLE AND NOTED A SMALL HOLE AT DISTAL TIP OF BALLOON. HE WOULD LIKE FOR IT TO BE EXAMINED. NOTHING NOTED AT INITIAL PREP OF BALLOON PRIOR TO CASE. THE BALLOON WAS INFLATED 15 ML DURING PREPARATION AND THE DEVICE WAS INTRODUCED THROUGH AN ER21B. NO RESISTANCE WAS NOTED DURING INSERTION/ ADVANCEMENT/ PLACEMENT. THE PATIENT HAD A CLEAR CTA PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756436 ↗
• MalfunctionFeb 25, 2025Infusion or Flow Problem; Infusion or Flow Problem

  EDWARDS RECEIVED A REPORT STATING AN ICF100 (INTRACLUDE) WOULD NOT FLUSH CARDIOPLEGIA DURING A ROBOTIC MITRAL VALVE REPAIR. THE BALLOON WAS PREPPED AND THERE WAS NO NOTED DEFECT WITH THE CATHETER. AN ER23B WAS USED TO INTRODUCE THE DEVICE. THE ICF100 WAS PLACED THROUGH THE ER23B WITHOUT COMPLICATIONS. THE ICF WAS PLACED IN THE ASCENDING AORTA. DURING BALLOON INFLATION, THE BALLOON WAS POSITIONED PROPERLY AND CARDIOPLEGIA WAS INITIATED. THE EVENT OCCURRED AFTER USE WITH THE FIRST CARDIOPLEGIA DOSE. THE INITIAL CARDIOPLEGIA DELIVERY RESULTED IN COMPLETE ARREST WITHOUT PRESSURE PROBLEMS; COLOR DOPPLER WAS USED TO VISUALIZE DELIVERY. WHEN CARDIAC ACTIVITY WAS NOTED, THE SUBSEQUENT CARDIOPLEGIA DELIVERY WAS UNABLE TO DELIVER. IT WAS NOTED WITH THE REDOSE THAT THERE WAS EXTREMELY HIGH LINE PRESSURE. BECAUSE OF INCREASED CARDIAC ACTIVITY, IT WAS DETERMINED THAT A NEW BALLOON WOULD BE PREPPED AND PLACED. AORTA 3.3 CM AT LOCATION OF BALLOON OCCLUSION. WHEN THE ICF WAS REMOVED IT WAS NOTED THAT THE BALLOON TIP ORIFICE WAS 'FISH-MOUTHED'. THE NEW ICF100 WAS PLACED AND UTILIZED WITHOUT COMPLICATIONS. THE HEART WAS ARRESTED AND THERE WAS NO PATIENT COMPLICATIONS EXCEPT DELAY OF PROCEDURE. PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21465211 ↗
• MalfunctionJun 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THERE WAS AN ICF100 BALLOON BURST DURING AN MVR CASE. APPROXIMATELY 200 MINUTES INTO THE CASE, THE SURGEON ASKED FOR THE BALLOON PRESSURE AND WAS ALERTED THAT IT WAS 70. THE CAMERA WAS MOVED TO VISUALIZE THE AORTA AND THE ICG9 SOLUTION WAS NOTED TO BE 'EVERYWHERE'. THERE WAS NO PATIENT INJURY DIRECTLY ATTRIBUTED TO THE DEVICE BURST. THE UNIT IS AVAILABLE FOR RETURN. ER23 WAS USED TO INTRODUCE THE DEVICE. NO ABNORMALITIES WERE NOTED DURING PREPARATION OF THE ICF100 AND THERE WAS NOT ANY DIFFICULTY ENCOUNTERED WHILE INSERTING THE DEVICE DURING THE PROCEDURE. NO UNUSUAL PATIENT ANATOMY WAS ENCOUNTERED DURING BALLOON PLACEMENT. LESS THAN 30CC HAD BEEN ADMINISTERED PRIOR TO RUPTURE. THE SUPPLIED EDWARDS SYRINGE WAS USED TO INFLATE THE BALLOON. AFTER RUPTURE, THE PROCEDURE WAS CONVERTED TO OPEN. THE PATIENT IS REPORTEDLY DOING FINE AND RECOVERING. ADDITIONAL INFORMATION REGARDING THE CASE WAS PROVIDED INCLUDING THE FOLLOWING: THERE WERE OTHER PROCEDURAL CONCERNS LEADING TO THE CONVERSION TO OPEN HEART SURGERY. THE BALLOON BURST WAS NOT THE ONLY FACTOR. THE SIZE OF THE AORTA AT THE STJ WAS 41MM. NO ISSUE IN POSITIONING DEVICE AND NO RESISTANCE WAS NOTED WHEN REMOVING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610888 ↗
• MalfunctionApr 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN ICF100 BALLOON RUPTURED DURING INITIAL INFLATION DURING AN MVR. THE ICF100 WAS FROM LOT BSLC0243 AND IS AVAILABLE FOR RETURN. THE DEVICE WAS REPLACED WITH A DEVICE FROM ANOTHER LOT. AN ER23 ENDORETURN WAS USED TO INTRODUCE THE DEVICE. THERE WERE NO KNOWN PATIENT FACTORS THAT COULD HAVE CONTRIBUTED TO THE RUPTURE OR UNUSUAL PATIENT ANATOMY. THE BALLOON WAS REPORTED TO BE PREPPED PER THE IFU, INFLATED TWICE DURING PREP, AND INFLATED WITH THE PROVIDED SYRINGE. THE SURGEON INSERTING THE BALLOON DID NOTE AN ABNORMAL VISUAL APPEARANCE PRIOR TO INSERTING THE BALLOON. INITIALLY THE BALLOON WAS INFLATED WITH 15CC OF INDOCYANINE GREEN. AT 15CC THE BALLOON RUPTURED. WHEN BALLOON WAS DEFLATED, IT WAS NOTED TO HAVE BLOOD IN THE SYRINGE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND REPLACED WITH A NEW DEVICE. NO PATIENT IMPACT OR HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093823 ↗
• InjuryApr 15, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  EDWARDS RECEIVED NOTIFICATION THAT THIS INTRACLUDE DEVICE MODEL IFC100 WAS DAMAGED DURING USE. THE PROCEDURE WAS A MITRAL VALVE REPAIR WITH INTRACLUDE CLAMPING. THE INTRACLUDE WAS POSITIONED IN THE ASCENDING AORTA WITH SOME DIFFICULTIES IN IDENTIFYING THE POSITION OF THE TIP OF THE DEVICE AND ADDITIONAL PLACEMENT MANEUVERS. THE AORTIC CLAMPING AND CARDIOPLEGIA DELIVERY SEQUENCE WAS INITIATED. AORTIC OCCLUSION WAS VISUALLY CONFIRMED ON TEE, BUT AORTIC ROOT PRESSURE DID NOT DROP AFTER OCCLUSION AND CARDIOPLEGIA DID NOT COMPLETELY STOP THE HEART, SHOWING HIGH PRESSURES AND LOW FLOWS. AFTER A SECOND ATTEMPT OF CARDIOPLEGIA DELIVERY, THE USE OF INTRACLUDE DEVICE WAS ABORTED, AND THE PROCEDURE CONTINUED WITH THE USE OF AN EXTERNAL CLAMP (CHITWOOD CLAMP). AS REPORTED, THE CATHETER WAS KINKED/TWISTED WHILE BEING PLACED IN THE AORTA. REPAIR WAS SUCCESSFUL AND THE MITRAL VALVE SHOWED JUST A TRIVIAL REGURGITATION. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THE ABORTED ATTEMPT TO CLAMP THE AORTA WITH THE INTRACLUDE DEVICE. REPORTEDLY, THE CANNULA AND ITS PACKAGING WERE INSPECTED PRIOR USE FOLLOWING THE INSTRUCTIONS FOR USE (IFU) AND NO ISSUES WERE OBSERVED BY THE MEDICAL TEAM NEITHER ON THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672153 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132175, K163693. One submission often covers many models, so check the product and lot details in each record.

• Z-1705-2019 · May 14, 2019 · Terminated
  IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use
• Z-1100-2019 · Jan 16, 2019 · Open, Classified
  Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip des
• Z-1929-2018 · Mar 30, 2018 · Terminated
  Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
• Z-1758-2015 · May 5, 2015 · Terminated
  Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a seale