Navitor™ NVTR-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 360 adverse event reports that list this exact device (DI 05415067031594), received between Oct 21, 2021 and Sep 18, 2026 — classified as 27 deaths, 305 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (105 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (P190023); 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.

Recalls naming this device

1. Oct 17, 2024Class IIOpen, Classified

   A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

   Z-0495-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 360 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult to Fold, Unfold or Collapse; Incomplete Coaptation; Intravalvular regurgitation

  It was reported that on (b)(6) 2026, a 27mm Navitor valve was selected for implant using a large FlexNav Delivery System (DS). Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 24mm, non-Abbott balloon. During the procedure, the valve was able to be implanted at a depth of approximately 5mm on the non-coronary cusp (NCC). Post-implant, severe transvalvular aortic regurgitation was observed with a gradient of 7.6mmHg. Transesophageal echocardiography (TEE) demonstrated markedly restricted mobility of one of the leaflets, resulting in inadequate leaflet coaptation and impaired hemodynamics presented with low blood pressure and high Left Ventricle (LV) end-diastolic pressure. Post-implant Balloon Aortic Valvuloplasty (post-BAV) was performed by using a 24mm, non-Abbott balloon. During post-BAV, angiography revealed significant recoil of the valve. Following post-BAV, no improvement in leaflet mobility, regurgitation severity, or hemodynamics were observed. While preparing for the second valve, the patient's conditions improved spontaneously with restoration of normal mobility of all three valve leaflets, improved hemodynamics and trace residual paravalvular l

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension

  MAUDE report 50818053 ↗
• InjuryJul 31, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 27mm Navitor valve was selected for implant using a FlexNav Delivery System (DS). The patient's aortic valve angle was 41 degrees. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 20mm, non-Abbott balloon. During the procedure, at 80 percent, the valve was placed at a depth of 3mm then the valve was able to be implanted. Upon removal of the DS, nosecone was observed to be entangled with the valve resulting in migration towards the aorta. A second 27mm, Navitor valve was implanted inside the index valve to resolve the event. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The implanter believed the cause of migration to be due to the nose cone entanglement. The patient was reportedly discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098368 ↗
• InjuryJul 31, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 27mm Navitor valve was selected for implant using a FlexNav Delivery System (DS). The patient has a horizontal anatomy with an aortic valve angle measured as 62 degrees. Aortic valve calcium was scored as moderate. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 20mm, non-Abbott balloon. During the procedure, at 80 percent, the valve was placed at a depth of 3-4mm below the annulus. Upon full release, the valve migrated into the ascending aorta. Post-procedure on the same day, the patient was developed with valve insufficiency and stenosis. On the following day, the valve was explanted and replaced with an unspecified (brand) valve surgically. The patient current health status is unknown. The final outcome was reportedly "recovered with sequelae".On follow-up, the patient had an extended hospitalization to 10 days. The patient is in a stable condition.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 50098169 ↗
• DeathMar 31, 2026Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT CONSISTS OF THT REGISTRY DATA FROM JAPAN. THE DATA DID NOT CONTAIN LOT NUMBER, UNIQUE DEVICE IDENTIFIER (UDI). THE INFORMATION WAS OBTAINED THROUGH THE REGISTRY, NO FURTHER DETAILS HAVE BECOME AVAILABLE FOR THIS EVENT. IT WAS REPORTED THROUGH THE THT REGISTRY FROM JAPAN THAT ON (B)(6) 2024, A 27MM NAVITOR VALVE WAS IMPLANTED. ON (B)(6) 2024, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS CARDIOVASCULAR, ORIGINATING FROM A CARDIOVASCULAR EVENT. THE DEATH WAS DUE TO HEART FAILURE, FOLLOWING REPEATED FEMORAL NECK FRACTURES.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24747136 ↗
• InjuryFeb 20, 2026Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Separation Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 27MM, NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAS A HORIZONTAL ANATOMY WITH THE VALVE MEASURING TO 57 DEGREES. AORTIC VALVE CALCIFICATION WAS CLASSIFIED AS SEVERE. DURING THE PROCEDURE, AT 80 PERCENT, THE VALVE WAS SEATED AT 3MM DEPTH. AFTER FULL DEPLOYMENT, ONE OF THE RETAINER TABS REMAINED OVER THE RETAINER RECEPTACLES AND WITH THE GENTLE MOVEMENT FROM THE GUIDEWIRE, THE VALVE POPPED UP. THE VALVE WAS PULLED UP OVER THE CORONARY ARTERIES USING A SNARE AND A SECOND 27MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DS. THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE IMPLANTER BELIEVES THE CAUSE OF MIGRATION TO BE DUE TO AN OPERATOR ERROR SINCE JUST BEFORE CONFIRMING THE RELEASE TO THE OTHER VIEW THE SECOND IMPLANTER PUSHED THE GUIDE WIRE BY MISTAKE AND THE VALVE POPPED UP. THE PATIENT WAS IN A DISCHARGED IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406319 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, 27MM NAVITOR WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING AN UNKNOWN BALLOON. DURING THE PROCEDURE, UPON DEPLOYMENT THE PATIENT WAS HYPOTENSIVE. ECHOCARDIOGRAM (ECG) REVEALED A PRESENCE OF CARDIAC TAMPONADE. A PERFORATION AT THE RIGHT VENTRICLE WAS DETECTED DUE TO THE TEMPORARY PACEMAKER. THE PROCEDURE WAS ABANDONED, AND THE PATIENT WAS TAKEN TO AN OPERATION THEATRE. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion

  MAUDE report 24101853 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM NAVITOR TRANSCATHETER AORTIC VALVE WAS CHOSEN FOR IMPLANT WITH THE LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT ALREADY HAD AN EXISTING 1ST DEGREE ATRIOVENTRICULAR BLOCK. THERE WAS CALCIFICATION PRESENT EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. THE FINAL IMPLANT DEPTH WAS 1MM BY 5MM. AFTER THE IMPLANT, THE PATIENT RECEIVED A PACEMAKER.

  Patient problems: Heart Block

  MAUDE report 23888071 ↗
• InjuryDec 19, 2025Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING AN UNKNOWN SIZED FLEXNAV DELIVERY SYSTEM (DS). DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY. HOWEVER, DUE TO HYPOMOBILE LEAFLET IT WAS DECIDED TO IMPLANT A SECOND VALVE. A NEW 27MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING AN UNKNOWN SIZED FLEXNAV DS. THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY. UNFORTUNATELY, THIS RESULTED IN CORONARY OCCLUSION. AT AN UNSPECIFIED TIME ON THE SAME DAY, THE PATIENT HAD DECEASED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854462 ↗
• DeathDec 19, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 20MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY AT A DEPTH OF 4MM ON THE NON-CORONARY CUSP (NCC). SEVERE CENTRAL REGURGITATION WAS NOTED. POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (POST-BAV) WAS PERFORMED USING AN UNKNOWN BALLOON. REGURGITATION REMAINED SEVERE. DUE TO HYPOMOBILE LEAFLET IT WAS DECIDED TO IMPLANT A SECOND VALVE. A NEW 27MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DS. THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 1 TO 2MM ON THE NON-CORONARY CUSP (NCC). UNFORTUNATELY, THIS RESULTED IN CORONARY OCCLUSION. THE USER ATTEMPTED TO SNARE THE VALVE. POST-PROCEDURE LESS THAN TWO HOURS, THE PATIENT HAD DECEASED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23854417 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 A 27MM NAVITOR TRANSCATHETER AORTIC VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT HAD A PRE-EXISTING RIGHT BUNDLE BRANCH BLOCK (RBBB). AFTER THE PER-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED, THE PATIENT WENT INTO COMPLETE HEART BLOCK. THE VALVE WAS IMPLANTED. THE FINAL IMPLANT DEPTH WAS 4MM FROM THE NON-CORONARY CUSP (NCC) AND 4MM FROM THE LEFT CORONARY CUSP (LCC). THE HEART BLOCK PERSISTED. THE FOLLOWING DAY A PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENT STATUS WAS STABLE.

  Patient problems: Heart Block

  MAUDE report 23795221 ↗
• InjuryDec 8, 2025Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY AT A DEPTH OF 3MM ON THE NON-CORONARY CUSP (NCC). ON (B)(6) 2025, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED MODERATE TO SEVERE REGURGITATION AND THE BIOPROSTHETIC CUSP IN THE TRADITIONAL RIGHT CORONARY CUSP POSITION IS NOT FUNCTIONING AND APPEARS TO BE ADHERENT TO THE ANTERIOR PORTION OF THE BIOPROSTHETIC STENT. VALVE-IN-VALVE PROCEDURE WAS NOT PERFORMED SINCE THE PATIENT REACHED AN OVERALL DECONDITIONING WITH A RISK TO COMORBIDITIES. THE PATIENT WAS DISCHARGED WITH AN INTENTION OF ENTERING INTO A HOSPICE CARE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23751809 ↗
• InjuryDec 2, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED ON (B)(6) 2025 A 27MM NAVITOR TRANSCATHETER AORTIC VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT'S ANNULUS WAS MEASURED AT A PERIMETER OF 75MM, AND THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) WAS 67MM. PRE-DILATION WAS PERFORMED WITH A 22MM NON-ABBOTT BALLOON. DURING THE PROCEDURE AT 80% DEPLOYMENT, THE VALVE DEPTH WAS 4MM FROM THE NON-CORONARY CUSP (NCC) AND 1MM FROM THE LEFT CORONARY CUSP (LCC). AT FULL DEPLOYMENT THE IMPLANT DEPTH ON THE LCC WAS 3MM AND THE NCC WAS 0MM WITH A MILD-SEVERE PERIVALVULAR LEAK. A SECOND 27MM NAVITOR TRANSCATHETER AORTIC VALVE WAS IMPLANTED AT AN IMPLANT DEPTH OF 4-5MM ON THE NCC AND 5MM ON THE LCC. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694727 ↗
• InjuryDec 1, 2025Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT¿S MINIMUM ANNULUS DIAMETER WAS MEASURED TO 19.8MM. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 20MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 0MM BOTH ON THE NON-CORONARY CUSP (NCC) AND LEFT-CORONARY CUSP (LCC). THE VALVE WAS NOTED TO HAVE MIGRATED TOWARDS AORTIC DIRECTION. THE VALVE WAS ATTEMPTED TO SNARE USING A 25MM, NON-ABBOTT DEVICE FOLLOWING A 23MM, NON-ABBOTT VALVE WAS ABLE TO BE IMPLANTED. THE PHYSICIAN BELIEVES THAT THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT¿S STATUS WAS RECOVERING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687387 ↗
• InjuryNov 26, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE ANNULUS PERIMETER AND MINIMUM DIAMETER WERE MEASURED TO BE 78.5MM AND 21.9MM RESPECTIVELY. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 23MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, THE INITIAL POSITION WAS NOTED TO BE HIGH AT THE NON-CORONARY CUSP (NCC). AT THE SECOND ATTEMPT, THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY AT A DEPTH OF 3-4MM ON THE NON-CORONARY CUSP (NCC). A MILD PVL WAS NOTED SO POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (POST-BAV) WAS PERFORMED USING THE SAME 23MM, NON-ABBOTT BALLOON AS AN INTERVENTION. AFTER POST-BAV, THE PATIENT DEVELOPED CHEST PAIN. ANGIOGRAM REVEALED CORONARY ARTERIES WERE NOT OBSTRUCTED. THE PATIENT'S CHEST PAIN SUBSEQUENTLY RESOLVED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. HOWEVER, FOLLOW-UP IMAGING LATER IDENTIFIED THE DEVELOPMENT OF AN AORTIC HEMATOMA FOR WHICH THE PATIENT WAS ADMITTED IN HOSPITAL FOR MONITORING. THE PATIENT'S STATUS WAS STABLE AND RECOVERING EXPECTED TO GET DISCHARGED O

  Patient problems: Angina; Hematoma

  MAUDE report 23662997 ↗
• InjuryOct 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  CLINICAL INFORMATION: CRD 1003 - VANTAGE, PATIENT SITE ID: (B)(6), (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2025, A SIGNIFICANT INCREASE IN THE MEAN TRANS PROSTHETIC GRADIENT (25MMHG) WAS NOTED. THE LEAFLET APPEARED TO BE SLIGHTLY THICKENED. A SUSPECTED THROMBUS ON THE VALVE. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS SCHEDULED IN ONE MONTH. THERE WAS NO TREATMENT REQUIRED. THE PATIENT WAS REPORTED IN STABLE CONDITION.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23323079 ↗
• InjurySep 29, 2025Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Off-Label Use; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM NAVITOR VALVE WAS CHOSEN FOR IMPLANTATION UTILIZING A LARGE FLEXNAV DELIVERY SYSTEM. AORTIC ANGLE WAS 63 DEGREES. SUFFICIENT CALCIUM PRESENT FOR ANCHORING. PATIENT PRESENTED WITH BICUSPID AORTIC VALVE, SIGNIFICANT LEAFLET CALCIFICATION, AND A CALCIUM BLOCK BETWEEN THE LEFT AND RIGHT SINUSES. PRE-DILATATION WAS PERFORMED WITH A 22MM BALLOON. NAVITOR VALVE WAS ADVANCED. AT 80% DEPLOYMENT, THE VALVE WAS UNDER EXPANDED AT A DEPTH OF 5MM. UNDER EXPANSION THOUGHT TO BE DUE TO EXCESS CALCIUM AND BICUSPID ANATOMY. IT WAS DECIDED TO RELEASE IN A LOWER POSITION WITH A PLANNED POST DILATATION. AFTER DEPLOYMENT AT 3MM THE VALVE MIGRATED TOWARDS AORTA. ALL TABS HAD RELEASED AND GUIDEWIRE WAS AT MIDVENTRICULAR POSITION. POST DILATATION WAS PERFORMED BUT FOLLOWING THIS, DEVELOPED AORTIC INSUFFICIENCY AND CARDIAC ARREST. CHEST COMPRESSIONS WERE PERFORMED. A SECOND 27MM NAVITOR VALVE WAS THEN IMPLANTED VALVE IN VALVE WITH A NEW LARGE FLEXNAV, BUT THE PATIENT REMAINED IN CARDIAC ARREST AND CHEST COMPRESSIONS CONTINUED. IT WAS THEN DECIDED TO PLACE THE PATIENT ON CARDIOPULMONARY BYPASS (CBP). AFTER THIS, IT WAS DISCOVERED THAT THE LEFT CORONARY ARTERY WAS P

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cardiac Arrest; Coronary obstruction/occlusion

  MAUDE report 23174494 ↗
• InjurySep 29, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM NAVITOR VALVE WAS CHOSEN FOR IMPLANTATION UTILIZING A LARGE FLEXNAV DELIVERY SYSTEM. AORTIC ANGLE WAS 63 DEGREES. SUFFICIENT CALCIUM PRESENT FOR ANCHORING. PATIENT PRESENTED WITH BICUSPID AORTIC VALVE, SIGNIFICANT LEAFLET CALCIFICATION, AND A CALCIUM BLOCK BETWEEN THE LEFT AND RIGHT SINUSES. PRE-DILATATION WAS PERFORMED WITH A 22MM BALLOON. NAVITOR VALVE WAS ADVANCED. AT 80% DEPLOYMENT, THE VALVE WAS UNDER EXPANDED AT A DEPTH OF 5MM. UNDER EXPANSION THOUGHT TO BE DUE TO EXCESS CALCIUM AND BICUSPID ANATOMY. IT WAS DECIDED TO RELEASE IN A LOWER POSITION WITH A PLANNED POST DILATATION. AFTER DEPLOYMENT AT 3MM THE VALVE MIGRATED TOWARDS AORTA. ALL TABS HAD RELEASED AND GUIDEWIRE WAS AT MIDVENTRICULAR POSITION. POST DILATATION WAS PERFORMED BUT FOLLOWING THIS, DEVELOPED AORTIC INSUFFICIENCY AND CARDIAC ARREST. CHEST COMPRESSIONS WERE PERFORMED. A SECOND 27MM NAVITOR VALVE WAS THEN IMPLANTED VALVE IN VALVE WITH A NEW LARGE FLEXNAV, BUT THE PATIENT REMAINED IN CARDIAC ARREST AND CHEST COMPRESSIONS CONTINUED. IT WAS THEN DECIDED TO PLACE THE PATIENT ON CARDIOPULMONARY BYPASS (CBP). AFTER THIS, IT WAS DISCOVERED THAT THE LEFT CORONARY ARTERY WAS P

  Patient problems: Cardiac Arrest

  MAUDE report 23174488 ↗
• InjurySep 8, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED ON (B)(6) 2025 A 27MM NAVITOR VISION VALVE WAS SELECTED FOR AN ENDO-BENTALL PROCEDURE. THE VALVE WAS SUTURED INTO A MODIFIED NON-ABBOTT ENDO-GRAFT. DURING THE PROCEDURE THE PHYSICIAN ACCIDENTALLY DEPLOYED THE VALVE IN THE SINUS OF VALSALVA (SOV). THE PATIENT WAS TRANSFERRED TO CARDIAC SURGERY TO REMOVE THE DEVICE AND REPAIR THE AORTIC ROOT. THE PATIENT STATUS WAS HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994236 ↗
• MalfunctionJul 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22482361 ↗
• InjuryJul 9, 2025Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED IN (B)(6) 2024 A 27MM NAVITOR TRANSCATHETER AORTIC VALVE WAS IMPLANTED. IN THE BEGINNING OF MAY 2024, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND WAS DIAGNOSED WITH HYPOATTENUATING LEAFLET THICKENING (HALT). ON (B)(6) 2024 THE PATIENT PRESENTED WITH TRANSVALVULAR AORTIC REGURGITATION AND A LEAFLET THROMBOSIS WAS DISCOVERED ON COMPUTED TOMOGRAPHY (CT). WARFARIN WAS INITIATED AS TREATMENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Thrombosis/Thrombus

  MAUDE report 22459893 ↗
• InjuryJul 7, 2025Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Off-Label Use; Improper or Incorrect Procedure or Method

  IT WAS REPORTED ON (B)(6) 2025 A 27MM NAVITOR TRANSCATHETER AORTIC VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT'S ANNULUS WAS MEASURED WITH THE PERIMETER AT 77.3MM, THE DIAMETER AT 24.6MM, AND THE AREA AT 423MM^2. THE PATIENT HAD A BICUSPID VALVE AND SEVERE LEAFLET CALCIFICATION. THE PATIENT'S AORTIC VALVE ANGLE WAS 46 DEGREES. THREE ATTEMPTS WERE MADE TO PRE-DILATE THE NATIVE VALVE WITH A 25MM NON-ABBOTT BALLOON BUT WERE UNSUCCESSFUL. ON THE FOURTH ATTEMPT THE BALLOON RUPTURED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE DECISION WAS MADE TO PROCEED WITH VALVE IMPLANT. DURING THE PROCEDURE, THE VALVE WAS RE-SHEATHED MORE THAN THREE TIMES. THE VALVE WAS THEN POSITIONED IN AN IDEAL POSITION, HOWEVER UPON FULL DEPLOYMENT THE VALVE WAS OBSERVED TO UNDER-EXPAND . THE FINAL IMPLANT DEPTH WAS 3MM FROM THE NON-CORONARY CUSP (NCC). A POST-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 23MM NON-ABBOTT BALLOON. THE VALVE EXPANDED MORE BUT WAS STILL NOT OPTIMAL. THE VALVE ALSO MIGRATED TOWARDS THE AORTA AS A RESULT OF THE POST-BAV. THE DECISION WAS MADE TO IMPLANT A SECOND 27MM NAVITOR TRANSCATHETER AORTIC VALVE. THE NATIVE VALVE WAS PRE-DILA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414502 ↗
• InjuryJul 7, 2025Difficult to Fold, Unfold or Collapse; Off-Label Use; Difficult to Fold, Unfold or Collapse; Off-Label Use

  IT WAS REPORTED ON (B)(6) 2025 A 27MM NAVITOR TRANSCATHETER AORTIC VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT'S ANNULUS WAS MEASURED WITH THE PERIMETER AT 77.3MM, THE DIAMETER AT 24.6MM, AND THE AREA AT 423MM^2. THE PATIENT HAD A BICUSPID VALVE AND SEVERE LEAFLET CALCIFICATION. THE PATIENT'S AORTIC VALVE ANGLE WAS 46 DEGREES. THREE ATTEMPTS WERE MADE TO PRE-DILATE THE NATIVE VALVE WITH A 25MM NON-ABBOTT BALLOON BUT WERE UNSUCCESSFUL. ON THE FOURTH ATTEMPT THE BALLOON RUPTURED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE DECISION WAS MADE TO PROCEED WITH VALVE IMPLANT. DURING THE PROCEDURE, THE VALVE WAS RE-SHEATHED MORE THAN THREE TIMES. THE VALVE WAS THEN POSITIONED IN AN IDEAL POSITION; HOWEVER, UPON FULL DEPLOYMENT THE VALVE WAS OBSERVED TO UNDER-EXPAND. THE FINAL IMPLANT DEPTH WAS 3MM FROM THE NON-CORONARY CUSP (NCC). A POST-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 23MM NON-ABBOTT BALLOON. THE VALVE EXPANDED MORE BUT WAS STILL NOT OPTIMAL. THE VALVE ALSO MIGRATED TOWARDS THE AORTA AS A RESULT OF THE POST-BAV. THE DECISION WAS MADE TO IMPLANT A SECOND 27MM NAVITOR TRANSCATHETER AORTIC VALVE. THE NATIVE VALVE WAS PRE-DILA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414481 ↗
• InjuryJun 19, 2025Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT'S AORTIC VALVE ANGLE (AV ANGLE FROM 3MENSIO) WAS 61°. A PRE-DILATION WAS PERFORMED WITH A 20MM NON-ABBOTT BALLOON. DURING PROCEDURE, THE VALVE IMPLANTATION HAD NON UNIFORM EXPANSION AND ALSO AT THE LEFT CORONARY SINUS (LCS) THE IMPLANT WAS NOMINAL. DURING PREPARATION FOR FINAL DEPLOYMENT, THE GUIDE WAS SLIGHTLY WITHDRAWN TO DIVERT THE CONE OF THE NOSE. AFTER SEVERAL ATTEMPTS BY THE CLINICAL SPECIALIST AND THEY NOTED THE VALVE WAS IN THE WRONG POSITION, BUT THE PHYSICIAN DECIDED TO CONTINUE THE IMPLANT AND THE VALVE MIGRATED TO THE ASCENDING AORTA. THE CAUSE OF MIGRATION WAS THE EXCESSIVE LEVEL OF CALCIUM. A POST DILATATION WAS NOT PERFORMED. A NEW 26MM NON-ABBOTT VALVE WAS IMPLANTED. THERE WAS NO DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289366 ↗
• InjuryJun 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214036 ↗
• InjuryJun 6, 2025Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Perivalvular Leak; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM NAVITOR VALVE (SN: (B)(6) WAS SELECTED FOR IMPLANTED IN A PATIENT WITH SEVERE AORTIC STENOSIS. THE PATIENT HAD AN AORTIC ANGLE OF 53 DEGREES AND THE ANNULAR DIMENSIONS: ANNULUS DIMENSIONS: MIN/MAX/AVG DIAMETER= 22.7/29.9/26.3MM, AREA/DERIVED DIAMETER= 520.3MM^2/25.7MM, PERIMETER/DERIVED DIAMETER: 82.2/26.2MM. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA. THE FEMORAL ARTERY WAS ACCESSED THROUGH A STANDARD ECHO-GUIDED PUNCTURE, AND A SUPER-STIFF PRE-SHAPED NON-ABBOTT GUIDEWIRE WAS PLACED IN THE LEFT VENTRICLE (LV). THE AORTIC VALVE WAS PRE-DILATED WITH A 22MM NON-ABBOTT BALLOON BEFORE THE TAVI DEVICE WAS INTRODUCED. THE 27MM VALVE WAS SELECTED BASED ON MDCT SIZING AND LOADED ONTO THE FLEXNAV DELIVERY SYSTEM (LOT: 10324771) ACCORDING TO THE IFU. THE TAVI DEVICE COULD NOT CROSS THE STENOTIC VALVE DUE TO THE STEEP AORTIC ENTRY ANGULATION CAUSED BY SEVERE AORTIC VALVE CALCIFICATION BETWEEN THE NON-CORONARY CUSP AND RIGHT CORONARY CUSP. THE TAVI DEVICE WAS RETRACTED FROM THE BODY. THE PHYSICIANS ATTEMPTED MULTIPLE TIMES TO RE-POSITION THE SUPER-STIFF WIRE IN THE LV TO CREATE A SMOOTHER ENTRY ANGLE BUT WERE UNSUCCESSFUL, EVEN WITH AN EXTR

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22159150 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P190023. One submission often covers many models, so check the product and lot details in each record.

• Z-0491-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
• Z-0492-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
• Z-0493-2025 · Oct 17, 2024 · Open, Classified
  Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
• Z-0494-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile