Navitor™ NVTR-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 249 adverse event reports that list this exact device (DI 05415067031600), received between Oct 20, 2021 and Jul 27, 2026 — classified as 28 deaths, 201 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (68 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-0492-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 249 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Material Split, Cut or Torn; Intravalvular regurgitation

  (b)(4) VISTA Nova, Patient Site ID: (b)(6).It was reported that on (b)(6) 2024, a 29mm Navitor Valve was chosen for implant. It was then reported on (b)(6) 2026, patient presented with severe aortic regurgitation. A transesophageal echocardiogram on (b)(6) 2026 confirmed presence of central aortic regurgitation due to a leaflet tear. No intervention or medical treatment was reported.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50019961 ↗
• DeathJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 29MM NAVITOR VALVE WAS CHOSEN FOR IMPLANTED. THE PATIENT WAS UNABLE TO UNDERGO THE TAVI PROCEDURE VIA THE TRANSFEMORAL APPROACH DUE TO THE PRESENCE OF AN AORTIC ANEURYSM. IT WAS DECIDED TO PROCEED WITH THE PROCEDURE VIA THE LEFT TRANS-CAROTID APPROACH. THE VALVE WAS POSITION AND AT APPROXIMATELY 80% OF DEPLOYMENT, IMPROPER POSITION WAS OBSERVED AND THE VALVE WAS RECAPTURED. THE DEPLOYMENT PROCESS WAS RESTARTED WITH PACING AT 120 BPM. DURING THE VALVE DEPLOYMENT, THE PATIENT DEVELOPED HEMODYNAMIC INSTABILITY, PROGRESSING TO HYPOTENSION AND VENTRICULAR FIBRILLATION. THEREFORE, THE VALVE WAS RECAPTURED AND RESUSCITATION MANEUVERS, INCLUDING DEFIBRILLATION, ADMINISTRATION OF EPINEPHRINE AND CHEST COMPRESSIONS WERE PERFORMED WITHOUT SUCCESS. AFTER THE FIRST RESUSCITATION CYCLE, THE PATIENT WAS STILL IN CARDIAC ARREST, THE VALVE WAS THEN DEPLOYED AND RESUSCITATION EFFORTS CONTINUED. HOWEVER, THE PATIENT PROGRESSED TO ASYSTOLE. ON ECHOCARDIOGRAPHIC ASSESSMENT, THE VALVE WAS FOUND TO BE IN AN APPROPRIATE POSITION. AFTER APPROXIMATELY 40 MINUTES OF RESUSCITATION EFFORTS, THE PATIENT PASSED AWAY.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Ventricular Fibrillation

  MAUDE report 25860435 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 29MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). BASELINE RHYTHM WAS RIGHT BUNDLE BRANCH BLOCK (RBBB). THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING AN UNKNOWN BALLOON. THE PATIENT WAS DEVELOPED WITH A COMPLETE HEART BLOCK, SO A TEMPORARY PACEMAKER WAS PLACED TO CONTINUE THE PROCEDURE. DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 3MM ON THE NON-CORONARY CUSP (NCC) AND 4MM ON THE LEFT-CORONARY CUSP (LCC). A TEMPORARY PACEMAKER WAS PLACED TO STABILIZE THE RHYTHM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. ON THE FOLLOWING DAY, THE PATIENT RECEIVED A PERMANENT PACEMAKER. THE PATIENT HAD AN EXTENDED HOSPITALIZATION. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: Heart Block

  MAUDE report 24537387 ↗
• InjuryMar 6, 2026Difficult to Fold, Unfold or Collapse; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2026, A 29MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAS A PRIOR MEDICAL HISTORY OF LEFT VENTRICULAR EJECTION FRACTION (LVEF) WITH 60%, HYPERTENSION, CHRONIC KIDNEY DISEASE (CKD), TUBERCULOSIS INFECTION AND COVID INFECTION. THE PATIENT PRESENTED WITH COMPLAINTS OF DYSPNEA AND DIZZINESS THAT HAD SLOWLY PROGRESSED OVER THE PAST ONE MONTH. THE PATIENT HAD A TYPE 1 BICUSPID AORTIC VALVE WITH HEAVILY CALCIFIED LEAFLETS. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 23MM AND A 25MM NON-ABBOTT BALLOON. IT WAS NECESSARY TO PERFORM PRE-BAV TWICE, AS THE ANNULAR OPENING REMAINED SUBOPTIMAL FOLLOWING THE INITIAL PRE-BAV. DURING THE PROCEDURE, THE VALVE WAS IMPLANTED AT A DEPTH OF 4MM ON THE NON-CORONARY CUSP (NCC) AND 3.8MM ON THE LEFT-CORONARY CUSP (LCC). TRACE PARAVALVULAR LEAK (PVL) WAS NOTED AND THE LEAK CONSIDERED AS ACCEPTABLE BY THE PHYSICIAN AND NO INTERVENTIONS OCCURRED. THE PATIENT WAS DISCHARGED. ON (B)(6) 2026, UPON CARDIAC CLEARANCE TESTS FOR A SCHEDULED ORTHO SURGERY, ON THE ECHOCARDIOGRAM (ECHO), HIGH MEAN PRESSURE GRADIENT WAS RECORDED WITH 73MMHG. THE PATIENT ALSO

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

  MAUDE report 24537303 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) - ENVISION IDE STUDY, PATIENT SITE (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE ACTIVATED CLOTTING LEVELS WERE 268,291S AND HEPARIN WAS GIVEN. A PRE-IMPLANT BALLOON VALVULOPLASTY WAS DONE WITH A 22MM NON-ABBOTT BALLOON. THE FINAL IMPLANT DEPTH AT NON-CORONARY CUSP (NCC) WAS 2.73MM AND AT LEFT CORONARY CUSP (LCC) WAS 6.7MM. AFTER THE PROCEDURE, THE PATIENT HAD A LEFT BUNDLE BRANCH BLOCK (LBBB). ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT HAD A SYNCOPAL EPISODE AND PERMANENT PACEMAKER WAS PLACED.

  Patient problems: Heart Block; Syncope/Fainting

  MAUDE report 24497819 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 29 MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). BASELINE WAS NOTED TO BE NORMAL SINUS RHYTHM. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING AN UNKNOWN BALLOON. THE PATIENT WENT INTO A COMPLETE HEART BLOCK, AND A TEMPORARY PACEMAKER WAS PLACED TO STABILIZE THE RHYTHM. DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 5MM ON THE NON-CORONARY CUSP (NCC) AND 6MM ON THE LEFT-CORONARY CUSP (LCC). ON THE FOLLOWING DAY, THE PATIENT RECEIVED A PERMANENT PACEMAKER. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: Heart Block

  MAUDE report 24490138 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 29MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). BASELINE WAS A NORMAL SINUS RHYTHM (NSR). PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 24MM, NON-ABBOTT BALLOON. THE PATIENT WAS DEVELOPED WITH A COMPLETE HEART BLOCK. A TEMPORARY PACEMAKER WAS PLACED TO CONTINUE THE PROCEDURE. DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 5MM ON THE NON-CORONARY CUSP (NCC) AND 6MM ON THE LEFT-CORONARY CUSP (LCC). THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. A TEMPORARY PACEMAKER WAS PLACED TO STABILIZE THE PATIENT. ON THE FOLLOWING DAY, THE PATIENT RECEIVED A PERMANENT PACEMAKER. THE PATIENT HAD AN EXTENDED HOSPITALIZATION. THE PATIENT WAS DISCHARGED.

  Patient problems: Heart Block

  MAUDE report 24475468 ↗
• InjuryFeb 24, 2026Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT (B)(6) 2026, A 29MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAD A HEAVILY CALCIFIED ANNULUS. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 23MM, NON-ABBOTT BALLOON. THE PATIENT WAS OBSERVED TO BE HYPOTENSIVE AND RECOVERED BY MANAGING WITH ANESTHETIC SUPPORT BY ADMINISTERING ADRENALINE. DURING THE PROCEDURE, AT THE TIME OF DEPLOYMENT, THE VALVE WAS POSITIONED AT 3MM DEPTH ACROSS THE ANNULUS. UPON RELEASE, THE VALVE MIGRATED ABOVE THE ANNULUS. THE VALVE WAS PULLED UP INTO THE ASCENDING AORTA USING A SNARE AND A NEW 29MM, NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DS. THE VALVE WAS ABLE TO BE IMPLANTED. POST-IMPLANT, NO CORONARY OBSTRUCTION WITH GOOD HEMODYNAMICS AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. THE PHYSICIAN BELIEVES A COMBINATION OF THE PRE-BAV BALLOON NOT BEING BIG ENOUGH AND SIGNIFICANT CALCIFICATION AT THE NCC CAUSED THE VALVE TO MIGRATE UP. THE PATIENT WAS DISCHARGED.

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

  MAUDE report 24432322 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 29MM NAVITOR TRANSCATHETER AORTIC VALVE WAS SELECTED FOR IMPLANT ON (B)(6) 2024. DURING DEVICE PREPARATION, WHILE LOADING THE VALVE ONTO THE LARGE FLEXNAV LOADING SYSTEM, THE FUNNEL WAS ACCIDENTALLY DROPPED BY THE PHYSICIAN AND WAS CONTAMINATED. THE LOADING SYSTEM WAS REPLACED WITH A NEW LARGE FLEXNAV DELIVERY SYSTEM. THE VALVE WAS IMPLANTED. ON AN UNKNOWN DATE A PERMANENT PACEMAKER WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24189788 ↗
• InjuryJan 6, 2026Perivalvular Leak; Device Stenosis

  CLINICAL INFORMATION: CRD_1059 - VISTA NOVA STUDY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT USING LARGE FLEXNAV DELIVERY SYSTEM. DURING PROCEDURE, THE ACTIVATED CLOTTING LEVELS WERE 248, 284S AND HEPARIN WAS GIVEN. A PRE-IMPLANT BALLOON VALVULOPLASTY WAS DONE WITH A 24MM NON-ABBOTT BALLOON. THE VALVE PARTIALLY RE-SHEATHED ONE TIME DUE TO THE IMPLANT DEPTH WAS TOO LOW. A POST-IMPLANT BALLOON VALVULOPLASTY WAS DONE WITH 26MM NON-ABBOTT BALLOON DUE TO MODERATE PERIVALVAR LEAK (PVL). THE FINAL IMPLANT DEPTH AT NON-CORONARY CUSP (NCC) WAS 0MM AND AT LEFT CORONARY CUSP (LCC) WAS 4MM. THE PATIENT CAME BACK FOR TWO YEAR FOLLOW UP AND INCREASED GRADIENT AND MARCOUMAR WAS STARTED. THE INTERNATIONAL NORMALIZED RATIO (INR) RANGE OF 2.0 TO 3.0. THE COMPUTERIZED TOMOGRAPHY (CT) SCAN CONFIRMED THERE WAS NO THROMBUS ON THE NAVITOR VALVE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23980032 ↗
• DeathNov 26, 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 29MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAD A PRIOR MEDICAL HISTORY OF SEVERE AORTIC STENOSIS, CORONARY ARTERY DISEASE MANAGED BY UNKNOWN MEDICATIONS, DIABETES MELLITUS, AND PREVIOUSLY DOCUMENTED A LEFT VENTRICULAR EJECTION FRACTION OF APPROXIMATELY 40 PERCENT. THE PATIENT HAD ARRIVED IN A STABLE CONDITION PRIOR TO THE PROCEDURE. THE PATIENT¿S AORTIC VALVE ANGLE WAS HORIZONTAL MEASURED TO BE 56 DEGREES AND HAD A TORTUOUS ANATOMY. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 23X40MM, NON-ABBOTT BALLOON. ANNULAR EXPANSION REMAINED INSUFFICIENT AND RESISTANCE PERSISTED. DURING THE PROCEDURE, DIFFICULTY IN ADVANCING THE DS THROUGH THE NATIVE ANNULUS WAS NOTED. A SECOND PRE-BAV WITH A LARGER BALLOON (25 MM) WAS THEN PERFORMED, WHICH EXCEEDS THE MINIMUM ANNULUS DIAMETER, BUT ALLOWED THE DS TO ADVANCE. AT THE INITIAL POSITION, THE FLUOROSCOPIC IMAGE REVEALED AORTIC REGURGITATION. IT WAS NOTED THAT THE VALVE REMAINED INSIDE THE CAPSULE AT THIS TIME. THE PATIENT DEVELOPED SEVERE HEMODYNAMIC INSTABILITY AND IT WAS DECIDED TO CONTINUE THE VALVE DEPLOYMENT. WHIL

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 23663043 ↗
• InjuryNov 26, 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 29MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAD A PRIOR MEDICAL HISTORY OF AORTIC STENOSIS AND RIGHT BUNDLE BRANCH BLOCK (RBBB). THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. THE BASELINE RHYTHM WAS NOTED TO BE NORMAL SINUS RHYTHM. A PRE-IMPLANT BALLOO AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING AN UNSPECIFIED BALLOON. THE PATIENT HAS DEVELOPED WITH A COMPLETE HEART BLOCK. DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY AT A DEPTH OF 1MM ON THE NON-CORONARY CUSP (NCC) AND 4MM ON THE LEFT-CORONARY CUSP (LCC). ECHOCARDIOGRAM (ECHO) REVEALED A WIDE QRS COMPLEX, BUT THE PATIENT STILL HAD THE CONDUCTION. A TEMPORARY PACEMAKER WAS PLACED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. ON THE FOLLOWING DAY, THE PATIENT WAS IMPLANTED WITH A PERMANENT PACEMAKER. THE PATIENT HAD AN EXTENDED HOSPITAL STAY FOR MONITORING OF RHYTHM. THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Arrhythmia; Heart Block

  MAUDE report 23662991 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 29MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. THE PATIENT WAS NOTED TO HAVE A NORMAL SINUS RHYTHM PRIOR TO THE PROCEDURE. A 12-LEAD EKG WAS PERFORMED PRE-CASE TO EVALUATE THE PATIENT¿S BASELINE CONDUCTION SYSTEM. THE VALVE WAS IMPLANTED AT A DEPTH OF 5MM BELOW THE ANNULUS ON THE NON-CORONARY CUSP SIDE USING A CUSP OVERLAP VIEW. A SIMILAR DEPTH OF 5MM WAS ACHIEVED ON THE LEFT CORONARY CUSP IN THE LEFT ANTERIOR OBLIQUE (LAO) VIEW, WITH PARALLAX REMOVED FROM THE VALVE. THE RATIONALE FOR CHOOSING A 5MM IMPLANT DEPTH ON BOTH CUSP SIDES WAS BASED ON THE PHYSICIAN¿S COMFORT WITH VALVE POSITIONING IN THIS PATIENT, AND IT WAS NOTED THAT THE VALVE WOULD NOT SIT WELL ANY HIGHER ON THE ANNULUS. NO CHALLENGES OR DEVIATIONS WERE NOTED DURING VALVE POSITIONING OR DEPLOYMENT. APPROXIMATELY FOUR HOURS AFTER THE IMPLANT PROCEDURE A WIDE QRS COMPLEX WAS OBSERVED. NO OTHER CONDUCTION ABNORMALITIES WERE NOTED IMMEDIATELY POST-IMPLANTATION. BASED ON THE TIMELINE OF EKG CHANGES, THE PHYSICIAN DECIDED TO IMPLANT A PERMANENT PACEMAKER LATER THAT EVENING. THE VALVE WAS REPORTED TO BE FUNCTIONING AS INTENDED POST-IMPLANTATION, WITH NO PARAVALVULAR LEAK AND

  Patient problems: Heart Block; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23518490 ↗
• InjuryOct 31, 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 29MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM (DS). THE PATIENT HAD PRIOR MEDICAL HISTORY INCLUDING SINUS BRADYCARDIA (SB) AND FIRST-DEGREE AV BLOCK. DURING THE PROCEDURE, THE VALVE WAS REPORTED TO BE IMPLANTED SUCCESSFULLY. ONE WEEK LATER ON AN UNKNOWN DATE, THE PATIENT RETURNED TO THE HOSPITAL AND RECEIVED A PERMANENT PACEMAKER. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT'S STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23442293 ↗
• InjuryOct 29, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAD A PRIOR MEDICAL HISTORY OF SEVERE AORTIC STENOSIS AND AORTIC VALVE INSUFFICIENCY. THE ANNULUS DIAMETER, AREA, AND PERIMETER OF THE NATIVE VALVE WERE MEASURED TO BE 26.9MM, 556.1MM2, AND 84.4MM RESPECTIVELY. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 23MM NON-ABBOTT BALLOON. THE VALVE WAS REPORTED TO BE IMPLANTED AT A DEPTH OF 9MM BOTH ON THE NON-CORONARY CUSP (NCC) AND LEFT-CORONARY CUSP (LCC). A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (POST-BAV) WAS PERFORMED USING A 25MM NON-ABBOTT BALLOON. ON (B)(6) 2025, THE PATIENT PRESENTED WITH SEVERE PERIVALVULAR LEAK (PVL). A 29MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DS. DURING THE PROCEDURE, A SNARE WAS USED TO ASSIST THE DS IN CROSSING THE PROSTHETIC VALVE. THE VALVE WAS IMPLANTED AT A DEPTH OF 2MM BOTH ON THE NON-CORONARY CUSP (NCC) AND LEFT-CORONARY CUSP (LCC) RESULTING IN MILD PVL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PHYSICIAN DOESN'

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23417489 ↗
• InjuryAug 15, 2025Difficult to Fold, Unfold or Collapse; Perivalvular Leak; Difficult to Fold, Unfold or Collapse; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM NAVITOR VALVE WAS CHOSEN FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A LARGE FLEXNAV DELIVERY SYSTEM. THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WERE DIAMETER MIN:23.8 MM, DIAMETER MAX:30.7MM, DIAMETER AVG: 27.3MM, AREA: 556.1MM^2, PERIMETER: 85.0MM/ LEFT VENTRICULAR OUTFLOW TRACT (LVOT): DIAMETER MIN:23.2 MM, DIAMETER MAX:30.5MM, DIAMETER AVG: 26.9MM, AREA: 545.6MM^2, PERIMETER: 84.3MM. DURING PROCEDURE, A PRE-DILATION WAS PERFORMED WITH A 23MM X 40 MM NON-ABBOTT BALLOON. AFTER THE FIRST DEPLOYMENT, A NON-UNIFORM EXPANSION (NUE) WAS PRESENT AND IT GOT RE-CAPTURED AND RELEASED, NUE DISAPPEAR. THE FINAL IMPLANT DEPTH WAS 4MM ON THE NON-CORONARY CUSP/NCC). AFTER THE IMPLANT, A MODERATE PERIVALVULAR LEAK WAS NOTED. A POST DILATATION WAS PERFORMED WITH A 25MM X 40 MM NON-ABBOTT BALLOON BUT (PVL) REMAINED. THE HEART TEAM DECIDED TO DELIVER A NON-ABBOTT VALVE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814782 ↗
• MalfunctionAug 12, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON 18 JULY 2025, A 29MM NAVITOR TRANSCATHETER AORTIC VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT'S ANNULUS WAS MEASURED WITH A PERIMETER OF 26.2MM. THE PATIENT'S THORACIC AORTA WAS KINKED. THE INITIAL IMPLANT DEPTH WAS 5MM FROM THE NON-CORONARY CUSP (NCC) AND 3MM FROM THE LEFT CORONARY CUSP (LCC). THE DECISION WAS MADE TO PLACE THE VALVE DEEPER TOWARD THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THE FINAL IMPLANT DEPTH WAS 6MM FROM THE NCC AND 5MM FROM THE LCC. DURING DETACHMENT OF THE THIRD RETAINER TAB, THE VALVE MOVED TO THE NCC SIDE AND RESTED AT 0MM INTRA-ANNULAR. 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 22784322 ↗
• MalfunctionJun 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM NAVITOR VALVE WAS CHOSEN FOR A PROCEDURE. DURING FLUOROSCOPIC INSPECTION, THE TEAM OBSERVED THAT THE STENT WAS ASYMMETRICAL, WHICH MADE IT IMPOSSIBLE TO DEPLOY THE PROSTHESIS. A NEW VALVE WAS CHOSEN AND COMPLETED THE PROCEDURE. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336536 ↗
• InjuryJun 18, 2025Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM NAVITOR VALVE WAS CHOSEN FOR IMPLANTATION UTILIZING A LARGE FLEXNAV DELIVERY SYSTEM. LOADING WAS PERFORMED BY ABBOTT EMPLOYEE WITHOUT ISSUE. HEPARIN ADMINISTERED, ACTIVATED CLOTTING TIME AT 250-300 SECONDS. THERE WAS DIFFICULTY PLACING THE VALVE AND SIX RE-CAPTURES WERE PERFORMED. ON THE SIXTH RECAPTURE, THE NAVITOR DID NOT FULLY RETRACT AFTER SEVERAL ATTEMPTS. MICROADJUSTMENT WHEEL WAS ATTEMPTING IN THE DESCENDING AORTA WITHOUT SUCCESS. THE DEVICE WAS ABLE TO BE REMOVED WITHOUT VASCULAR DAMAGE OR INTERVENTION. DURING EVALUATION OUTSIDE OF THE PATIENT, AN UNKNOWN FRAGMENT WAS OBSERVED BETWEEN THE VALVE AND FLEXNAV. IT WAS UNKNOWN WHETHER IT WAS THROMBUS OR TISSUE DAMAGE. NO ADDITIONAL INTERVENTION WAS PERFORMED IN RESPONSE TO THE FRAGMENT. THE NAVITOR VALVE AND FLEXNAV WERE REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 22288743 ↗
• InjuryMay 5, 2025Migration or Expulsion of Device; Perivalvular Leak; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Intravalvular regurgitation; Migration or Expulsion of Device; Perivalvular Leak; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Intravalvular regurgitation

  N/A.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Vascular Dissection

  MAUDE report 21960386 ↗
• InjuryMay 2, 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 29 MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. DURING PROCEDURE, AT 80% THE VALVE SEEMS TO BE AT NORMAL IMPLANT DEPTH BUT AT THE FINAL RELEASE, THE VALVE EXPERIENCED A MIGRATION TOWARDS AORTA. THE AORTA WAS AN HORIZONTAL ONE. THE VALVE SEEMS TO BE RELEASED INTO THE ANNULUS BUT SLOWLY MOVE UP AFTER THE RELEASING. AN ADDITIONAL NON-ABBOTT VALVE WAS IMPLANTED. THE MIGRATED VALVE WAS SNARED TO BRING STABILITY TO THE SECOND IMPLANTED VALVE. THE SNARED VALVE WAS NOT REPOSITIONED. THE PATIENT EXPERIENCED NO CORONARY ARTERY OCCLUSION. THE PHYSICIAN MENTIONED THE CAUSE OF MIGRATION WAS HORIZONTAL AORTA. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950276 ↗
• DeathApr 28, 2025Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  N/A.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 21919911 ↗
• InjuryApr 17, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. THE ANNULAR DIMESONS OF THE NATIVE VALVE WERE PERIMETER 81.4MMAND MEDIUM RING 25MM AND A PRE-DILATATION WAS PERFORMED WITH A 25 BALLOON. THE IMPLANT DEPTH AT 80% WAS ABOUT 4-5MM AND THE IMPLANT DEPTH AT RELEASE PRIOR TO MIGRATION WAS ABOUT 4-5MM. THE VALVE WAS IMPLANTED AFTER 2 PARTIAL RECAPTURES FOR OPTIMAL POSITIONING AND 0 CONTROL LEAKS AFTER 100% DEPLOYMENT. A FEW HOURS AFTER THE PROCEDURE, IT WAS NOTED THAT THE VALVE WAS MIGRATED TO THE AORTIC ARCH. A TRANSCATHETER VALVE IMPLANTATION (TAVI) WAS PERFORMED AND A NON-ABBOTT VALVE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857895 ↗
• InjuryApr 7, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM NAVITOR VALVE WAS IMPLANTED USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE IMPLANT DEPTH OF THE VALVE WAS 3MM AT NCC AND 4MM AT LCC. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE IS: ANNULUS DIAM 25.4MM, AREA 492.3, PERIMETER 79.5MM, AND LVOT DIAM 25.5MM. IT WAS NOTED THAT THERE WAS ADEQUATE CALCIFICATION TO ALLOW ANCHORING OF THE DEVICE AND THE AORTIC ANGLE WAS 74 DEGREES. IT WAS NOTED THAT THE DEVICE MIGRATED TOWARD THE AORTA AND A SECOND 29MM NAVITOR VALVE WAS IMPLANTED VALVE-IN-VALVE TO RESOLVE THE EVENT. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21792898 ↗
• InjuryApr 7, 2025Migration or Expulsion of Device; Perivalvular Leak; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Perivalvular Leak; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. A PRE-DILATION WAS PERFORMED USING A 21MM NON-ABBOTT DEVICE. IT WAS NOTED DURING PROCEDURE, THAT THE VALVE MIGRATED TOWARD THE LEFT VENTRICLE UPON FINAL DEPLOYMENT. THE VALVE WAS RE-SHEATHED ONCE DURING PROCEDURE. AT 80% AND AT FINAL DEPLOYMENT, THE IMPLANT DEPTH OF THE VALVE WAS AT 4MM. PRIOR TO FINAL DEPLOYMENT THE DELIVERY SYSTEM WAS IN NEUTRAL POSITION/TO SLIGHT FORWARD PRESSURE. THE GUIDEWIRE WAS PULLED TO A MIDVENTRICULAR POSITION TO DEFLECT NOSECONE AND TWO DIFFERENT VIEWS WERE USED TO CONFIRM ALL 3 RETAINERS TABS HAD RELEASED. THE PATIENT'S AORTIC VALVE ANGLE WAS 41 DEGREES. THE MIGRATED VALVE DID NOT BLOCK A CORONARY ARTERY OR ARTERIES. THERE WAS NO ENTANGLEMENT WITH THE DELIVERY SYSTEM AND VALVE WHILE REMOVING THE DELIVERY SYSTEM AFTER FINAL DEPLOYMENT. POST-IMPLANT, A SUPRASKIRTAL LEAK WAS ALSO NOTED. THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE VALVE. THE DECISION WAS MADE TO ATTEMPT SNARING OF THE VALVE. A SECOND 27MM NAVITOR VALVE WAS IMPLANTED IN A VALVE-IN-VALVE PROCEDURE TO STOP AORTIC REGURGITATION. THERE WAS NO INITIAL OR PROLONGED H

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21792585 ↗

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-0495-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
• Z-0494-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
• Z-0493-2025 · Oct 17, 2024 · Open, Classified
  Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile