Navitor Titan™ NVRO-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 05415067045768), received between Mar 5, 2024 and Sep 18, 2026 — classified as 12 deaths, 110 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (26 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-0491-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 143 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Premature Separation

  It was reported that on 26 Aug. 2026, a 35mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). Femoral vessel was selected as the access site, and the patient was in a normal sinus rhythm with pre-gradient measured as 49mmHg. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 26mm, non-Abbott balloon. During the procedure, on the first attempt, the valve was positioned too high and it was required to be recaptured. On the second attempt, non-Abbott wire pushed the valve to jump up higher therefore the DS was pulled into the ascending aorta and a recapture was performed. On fluoroscopy, kink was observed and it was reported that all (3) retainer tabs were detached and removed from the patient's anatomy with the gap closed. A second 35mm, Navitor Vision valve was selected for implant using a new large FlexNav DS. The valve was recaptured due to the positioning issues, and it was pulled into the ascending aorta to recapture the valve. During the recapture, it was observed that the valve had detached partially and it was removed from the patient's anatomy with the gap closed. A third 35mm, Navitor Vision valve was selecte

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819235 ↗
• MalfunctionSep 18, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2026, a 35mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). Femoral vessel was selected as the access site, and the patient was in a normal sinus rhythm with pre-gradient measured as 49mmHg. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 26mm, non-Abbott balloon. During the procedure, on the first attempt, the valve was positioned too high and it was required to be recaptured. On the second attempt, non-Abbott wire pushed the valve to jump up higher therefore the DS was pulled into the ascending aorta and a recapture was performed. On fluoroscopy, kink was observed and it was reported that all (3) retainer tabs were detached and removed from the patient's anatomy with the gap closed. A second 35mm, Navitor Vision valve was selected for implant using a new large FlexNav DS. The valve was recaptured due to the positioning issues, and it was pulled into the ascending aorta to recapture the valve. During the recapture, it was observed that the valve had detached partially and it was removed from the patient's anatomy with the gap closed. A third 35mm, Navitor Vision valve was selected

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819220 ↗
• MalfunctionSep 18, 2026Premature Separation

  It was reported that on 26 Aug. 2026, a 35mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). Femoral vessel was selected as the access site, and the patient was in a normal sinus rhythm with pre-gradient measured as 49mmHg. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 26mm, non-Abbott balloon. During the procedure, on the first attempt, the valve was positioned too high and it was required to be recaptured. On the second attempt, non-Abbott wire pushed the valve to jump up higher therefore the DS was pulled into the ascending aorta and a recapture was performed. On fluoroscopy, kink was observed and it was reported that all (3) retainer tabs were detached and removed from the patient's anatomy with the gap closed. A second 35mm, Navitor Vision valve was selected for implant using a new large FlexNav DS. The valve was recaptured due to the positioning issues, and it was pulled into the ascending aorta to recapture the valve. During the recapture, it was observed that the valve had detached partially and it was removed from the patient's anatomy with the gap closed. A third 35mm, Navitor Vision valve was selecte

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819205 ↗
• InjuryAug 31, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 35mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). The patient has a prior medical history of cardiac amyloidosis but no arrhythmias. The patient's aortic valve was measured to be 47 degrees. The length of the membranous septum was 6.8mm. There was calcification extending beneath the aortic annular plane in the interventricular septum. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 25mm, non-Abbott balloon. Following pre-BAV, the patient was developed with a heart block. During the procedure, at 80 percent, the valve was placed at a depth of 3-4mm then the valve was able to be implanted. Post-implant, heart block progressed to a complete heart block, and the patient was observed with asystole requiring chest compressions. A temporary pacemaker was placed to stabilize the cardiac rhythm, and the patient was also intubated. Medications were administered to treat the condition; after 3 minutes of chest compressions, the patient regained pulse. DS was removed from the patient's anatomy, but the valve was observed to have migrated upwards; no paravalvular leak (PVL) was observ

  Patient problems: Cardiac Arrest; Heart Block

  MAUDE report 50531241 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6)2026, a 35 mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System (DS). The patient had a prior medical history of Coronary Artery Bypass Graft (CABG), heart failure, hypertension, diabetes, ischemic heart disease, Parkinson¿s disease, gastritis, and anemia. During device preparation, the valve was loaded by an Abbott employee. No issues were reported with retracting the valve into the delivery system or leading the retainer tabs into the retainer receptacle. The valve was observed to enter the capsule slowly during loading. It was reported that loading was harder than usual, but no excess force was required to turn the resheath wheel. The deploy/resheath wheel did not reach the end of travel, and an approximately 4-5 mm gap remained. The gap was subsequently closed using the micro-adjustment wheel. The procedure was performed under general anesthesia. The patient was reported to have calcified femoral vessels, and the heart team elected to obtain vascular access via surgical cutdown. A 14 Fr non-Abbott introducer sheath was used with a 26 mm non-Abbott balloon for pre-dilatation and was subsequently removed. The DS was

  Patient problems: Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 50180773 ↗
• DeathAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 35mm Navitor Vision Valve was chosen for implant using a Large FlexNav Delivery System. The patient had a history of severe symptomatic aortic stenosis, a small pericardial effusion and bilateral pleural effusion was noted pre-procedure. The physician decided to perform a post-BAV with a 26mm True Balloon. However, the balloon was unable to be withdrawn into the 14Fr sheath after multiple attempts. While preparing to remove the balloon and sheath through the arteriotomy, there was a decrease in blood pressure noted. Anesthesia administered medication to raise the blood pressure, however, the patient's blood pressure remained unstable. An aortogram was performed and it was noted that the patient had wide open aortic insufficiency. Cardiac tamponade was not observed. The patient was then intubated and CPR was required for stabilization and to circulate medication. The Navitor was deployed to 80%, but hemodynamic instability persisted. CPR was reinitiated and medication continued to be administered. The valve was deployed and an Impella was placed to help suppose the patient hemodynamically. Assessment of the positioning and depth of the valve we

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50135357 ↗
• MalfunctionJul 1, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). DURING THE PROCEDURE, ON 80 PERCENT OF THE DEPLOYMENT, AN INCOMPLETE STENT OPENING (ISO) WAS OBSERVED AND A RECAPTURE WAS ATTEMPTED TO REDEPLOY. HOWEVER, THE VALVE WAS UNABLE TO BE RECAPTURED COMPLETELY; MICRO-ADJUSTMENT WHEEL WAS USED WHEN THE DS WAS PULLED AT THE DESCENDING AORTA, BUT THE GAP REMAINED UNCHANGED. THE DS WITH THE HALF-CAPTURED VALVE WAS REMOVED FROM THE PATIENT'S ANATOMY THROUGH A 20FR UNSPECIFIED SHEATH. A NEW 35MM, NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A NEW LARGE FLEXNAV DS/ DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. THE USER BELIEVES THE VALVE EXPANDED NON-UNIFORMLY DUE TO THE EXCESS CALCIUM. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680876 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6). 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT DID NOT HAVE A HISTORY OF RIGHT BRANCH BUNDLE BLOCK (RBBB), LEFT BUNDLE BRANCH BLOCK (LBBB) OR1ST/2ND DEGREE ATRIOVENTRICULAR (AV) BLOCK. THE LENGTH OF THE MEMBRANOUS SEPTUM WAS NOT MEASURED. THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. BASELINE WAS NORMAL SINUS RHYTHM (NSR). PRE-IMPLANT BALLOON VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 25MM, NON-ABBOTT BALLOON WITH THE SUPPORT OF TEMPORARY PACING AT 180 BEATS PER MINUTE. DURING THE PROCEDURE ON THE FIRST ATTEMPT, AT 80 PERCENT, THE VALVE WAS OBSERVED TO BE LOW, SO A PARTIAL RECAPTURE WAS PERFORMED. ON THE SECOND ATTEMPT, THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY AT A DEPTH OF 4MM BOTH ON THE NON-CORONARY CUSP (NCC) AND LEFT-CORONARY CUSP (LCC). POST-PROCEDURE LESS THAN 48 HOURS, THE PATIENT WAS OBSERVED TO BE IN NSR WITH A NEW LEFT BUNDLE BRANCH BLOCK (LBBB). THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. ON THE FOLLOWING DAY, THE PATIENT WAS D

  Patient problems: Heart Block

  MAUDE report 25236957 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). BASELINE WAS SINUS RHYTHM WITH RIGHT BUNDLE BRANCH BLOCK (RBBB). THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. PRE-IMPLANT BALLOON VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 25MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 3 TO 4MM ON THE NON-CORONARY CUSP (NCC) AND 4MM ON THE LEFT-CORONARY CUSP (LCC) WITHOUT RECAPTURE. NO INCOMPLETE STENT OPENING (ISO) WAS OBSERVED. FINAL GRADIENT WAS 7MMHG; NO LEAK WAS REPORTED. POST-IMPLANT, THE PATIENT WAS OBSERVED TO HAVE A SINUS RHYTHM WITH LEFT BUNDLE BRANCH BLOCK (LBBB). 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 TO RESOLVE THE EVENT. THE IMPLANTER CLASSIFIED THIS EVENT AS BEING RELATED TO THE PROCEDURE AND THE PATIENT¿S PAST MEDICAL HISTORY. THE PATIENT WAS IN A STABLE CONDITION AND REPORTED TO BE IN HOSPITAL.

  Patient problems: Heart Block

  MAUDE report 25176446 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_1066 - ENVISION IDE STUDY, PATIENT SITE: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2026, A 29MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. A PRE-IMPLANT BALLOON VALVULOPLASTY WAS DONE WITH A 24MM NON-ABBOTT BALLOON. THE FINAL IMPLANT DEPTH AT NON-CORONARY CUSP (NCC) WAS 2.6MM AND LEFT CORONARY CUSP (LCC) WAS 4.6MM. FOLLOWING THE PRE-BAV, THE PATIENT WENT INTO ATRIAL FIBRILLATION AND A LEFT BUNDLE BRANCH BLOCK (LBBB). THIS WAS SUSTAINED THROUGH THE REST OF THE PROCEDURE. AMIODARONE AND ELIQUIS WERE ADMINISTERED AS TREATMENT. BOTH WERE RESOLVED THE FOLLOWING DAY AND THE PATIENT WAS DISCHARGED ON (B)(6) 2026.

  Patient problems: Atrial Fibrillation; Heart Block

  MAUDE report 25175266 ↗
• InjuryApr 27, 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) 2026, A 35MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. A PRE-IMPLANT BALLOON VALVULOPLASTY WAS DONE WITH A 28MM NON-ABBOTT BALLOON. THE VALVE GOT FULLY RE-SHEATHED 1 TIME DUE TO THE IMPLANT BEING TOO HIGH. THE FINAL IMPLANT DEPTH AT NON-CORONARY CUSP (NCC) WAS 4.55MM AND LEFT CORONARY CUSP (LCC) WAS 3.16MM. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED AN EPISODE OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT). FOR TREATMENT, 2G IV MAGNESIUM SULFATE WAS ADMINISTERED. THE PATIENT WAS THEN MONITORED FOR AN ADDITIONAL DAY. ON (B)(6) 2026, THE VT WAS RESOLVED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Tachycardia

  MAUDE report 25004680 ↗
• DeathApr 24, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6)2026, a 35mm Navitor Vision valve was selected for implant using a small FlexNav Delivery System (DS). The patient has a prior medical history of Right Branch Bundle Block (RBBB). Prior to the procedure, the patient was in a stable condition. There was no calcification extending beneath the aortic annular plane in the interventricular septum. During the pre-implant Balloon Valvuloplasty, the patient experienced cardiac arrest followed by ventricular fibrillation; pre-BAV was performed using a 26mm, non-Abbott balloon. The physician immediately proceeded with implantation of the valve in an attempt to stabilize the patient. During the procedure, the valve was able to be implanted at a depth of 4mm on the non-coronary cusp (NCC), however, the patient remained in atrioventricular fibrillation. Cardiopulmonary resuscitation (CPR) maneuvers were initiated, associated with the use of an Automated External Defibrillator (AED), with multiple attempts at rhythm reversal every two minutes. Concurrently, the echocardiographer performed a detailed evaluation to rule out pericardial effusion and to investigate other parameters that could explain the event. No abnor

  Patient problems: Atrial Fibrillation; Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 24986754 ↗
• DeathApr 17, 2026Difficult to Fold, Unfold or Collapse; Adverse Event Without Identified Device or Use Problem; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35 MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 3-4 MM ON THE NON-CORONARY CUSP (NCC). NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED. ON THE FOLLOWING DAY, THE PATIENT HAD CLINICAL CONDITION HAD DETERIORATED WITH HEMODYNAMIC INSTABILITY BEING OBSERVED. POST-IMPLANT BALLOON VALVULOPLASTY (POST-BAV) WAS PERFORMED USING A 24 MM AND TWICE WITH 26 MM, NON-ABBOTT BALLOON. ON THE FOLLOWING DAY, THE PATIENT WAS PRONOUNCED TO DECEASED. THE IMPLANTER CLASSIFIED THIS DEATH LIKELY RELATED TO THE PROCEDURE AND THE PATIENT¿S COMORBIDITIES SINCE HE STATED THAT THE VALVE LOOKED FINE.

  Patient problems: Aortic Valve Stenosis; Low Blood Pressure/ Hypotension

  MAUDE report 24916120 ↗
• DeathApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35 MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAS A PRE-EXISTING MITRAL AND TRICUSPID REGURGITATION ALONG WITH A HISTORY OF ATRIAL FIBRILLATION AND HAS A WATCHMAN DEVICE IN PLACE. THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. PRIOR TO THE IMPLANT, THE PATIENT WAS DESCRIBED AS "SERIOUSLY ILL". DURING THE PROCEDURE, AT INITIAL ATTEMPT, THE VALVE WAS POSITIONED AT A DEPTH OF 4 MM ON THE NON-CORONARY CUSP (NCC) AND 8 MM ON THE LEFT-CORONARY CUSP (LCC) AND IT WAS RECAPTURED AND REPOSITIONED AT A DEPTH OF 4 MM ON THE NCC; HOWEVER, CONFIRMATION OF PLACEMENT ON THE LEFT SIDE WAS LIMITED DUE TO RESTRICTED CONTRAST VISIBILITY. DURING THE ASSESSMENT, THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY, AND BECAME CRITICALLY HEMODYNAMICALLY UNSTABLE. MULTIPLE EFFORTS WERE UNDERTAKEN TO STABILIZE THE PATIENT, INCLUDING THE INITIATION OF CARDIOPULMONARY RESUSCITATION (CPR). DUE TO ONGOING INSTABILITY AND DIFFICULTY CONFIRMING THE VALVE POSITION, A DECISION WAS MADE TO FULLY RECAPTURE THE VALVE. CPR WAS CONTINUED, AND EXTRACORPOREAL MEMBRANE O

  Patient problems: Insufficient Information

  MAUDE report 24916119 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6) - ENVISION IDE STUDY, PATIENT SITE (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 35MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. A PRE-IMPLANT BALLOON VALVULOPLASTY WAS DONE WITH A 26MM NON-ABBOTT BALLOON. THE PATIENT DEVELOPED A COMPLETE ATRIOVENTRICULAR BLOCKAGE FOLLOWING THE PRE-DEPLOYMENT BALLOON VALVULOPLASTY. A TEMPORARY FIXATING PACING LEAD WAS PLACED IN THE RIGHT VENTRICLE. THE FINAL IMPLANT DEPTH AT NON-CORONARY CUSP (NCC) WAS 4.4MM AND LEFT CORONARY CUSP (LCC) WAS 5.6MM. PRIOR TO DISCHARGE, THE PATIENT WAS EXPERIENCING SIGNIFICANT VISION LOSS. A PERMANENT PACEMAKER WAS THEN IMPLANTED ON (B)(6) 2025, TO TREAT THE HEART BLOCK. THE PATIENT WAS SUBSEQUENTLY DISCHARGED THE SAME DAY WITH IMPROVEMENT IN THEIR VISION.

  Patient problems: Blurred Vision; Heart Block

  MAUDE report 24781621 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAS A PRIOR MEDICAL HISTORY OF LEFT BRANCH BUNDLE BLOCK (LBBB) WITH ATRIOVENTRICULAR (AV) BLOCK. THE LENGTH OF THE MEMBRANOUS SEPTUM WAS 3.8MM. THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 5MM ON THE NON-CORONARY CUSP (NCC). THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. POST-IMPLANT, CONDUCTION ABNORMALITIES REMAINED UNCHANGED; TEMPORARY PACEMAKER WAS PLACED AND THE PATIENT RECEIVED A PERMANENT PACEMAKER TO RESOLVE THE EVENT. THE IMPLANTER CLASSIFIED THIS EVENT AS BEING RELATED TO THE PROCEDURE AND THE PATIENT'S PAST MEDICAL HISTORY. THE PATIENT WAS DISCHARGED.

  Patient problems: Arrhythmia

  MAUDE report 24749809 ↗
• MalfunctionMar 30, 2026Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). UPON INTRODUCTION OF THE DS INTO THE PATIENT¿S ANATOMY, IT WAS NOTED TO BE UPSIDE DOWN. DURING THE PROCEDURE, AT 80 PERCENT WHILE DEPLOYING THE VALVE, THE DEPLOYMENT BUTTON DID NOT POP UP AND THERE WAS NO HARD STOP OR CLICK SOUND HEARD WITH THE DEPLOYMENT/RESHEATH WHEEL. AS A RESULT, THE VALVE WAS FULL DEPLOYED UNINTENTIONALLY AND IT WAS REPORTED THAT THE PHYSICIAN DIDN'T ACCIDENTALLY PUSH THE BUTTON. THE VALVE WAS OBSERVED TO BE IMPLANTED AT AN OPTIMAL DEPTH OF 4.5MM ON THE NON-CORONARY CUSP (NCC), AND NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED. THE PATIENT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24720555 ↗
• MalfunctionMar 30, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE 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, THE IMAGING REVEALED THE VALVE WAS IN FOLDED (PALMITO EFFECT) SO, IT WAS REMOVED FROM THE PATIENT'S ANATOMY AND A NEW 35MM, NAVITOR VISION VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719447 ↗
• InjuryMar 23, 2026Difficult to Fold, Unfold or Collapse; Off-Label Use; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT HAD A TYPE 1 BICUSPID ANNULUS WITH A CALCIFIED RAPHE. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING AN UNKNOWN BALLOON. DURING THE PROCEDURE, INCOMPLETE STENT OPENING (ISO) WAS NOTED AND MITIGATED AS PER THE ESTABLISHED STEPS AND THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 3MM BOTH ON THE NON-CORONARY CUSP (NCC) AND LEFT-CORONARY CUSP (LCC). POST-IMPLANT, MODERATE AORTIC REGURGITATION WAS NOTED AND TREATED MEDICALLY. POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (POST-BAV) WAS PERFORMED USING A NON-ABBOTT BALLOON; REGURGITATION REMAINED UNCHANGED. ON AN UNKNOWN DATE, THE PATIENT WAS DEVELOPED WITH HEART FAILURE. ON (B)(6) 2026, A NON-ABBOTT VALVE WAS IMPLANTED BY PERFORMING A VALVE-IN-VALVE PROCEDURE RESULTING IN NO LEAK. THE PATIENT HAD AN EXTENDED HOSPITALIZATION. THE PATIENT WAS IN A STABLE CONDITION AND SUBSEQUENTLY DISCHARGED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure

  MAUDE report 24667106 ↗
• MalfunctionMar 10, 2026Difficult to Fold, Unfold or Collapse; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAD A HIGHLY CALCIFIED AORTIC VALVE. A FLUOROSCOPY CHECK WAS CONFIRMED. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 28MM, UNKNOWN BALLOON. DURING THE PROCEDURE, ON THE INITIAL ATTEMPT AT 80 PERCENT, IT WAS POSITIONED HIGH, SO IT WAS RECAPTURED. ON THE SECOND ATTEMPT AT 80 PERCENT, POOR VALVE UNDEREXPANSION WAS NOTED AND ABLE TO BE RECAPTURED AFTER USING THE MICRO-ADJUSTMENT WHEEL. A NEW VALVE WAS LOADED AND ABLE TO BE IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. IT WAS NOTED THAT THE PROCEDURE TIME WAS INCREASED. THE PATIENT'S STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565817 ↗
• InjuryFeb 27, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAS A HORIZONTAL ANATOMY MEASURING TO BE 50 DEGREES. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 25MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, AT 80 PERCENT DEPLOYMENT, THE VALVE WAS PLACED AT 3MM DEPTH. THE VALVE WAS ABLE TO BE IMPLANTED, AND IT WAS OBSERVED TO BE EMBOLIZED TOWARDS AORTA. POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (POST-BAV) WAS PERFORMED USING A 28MM, NON-ABBOTT BALLOON. THE DEVICE WAS REPOSITIONED VIA A SNARE AND THE PATIENT BECAME UNSTABLE. A SURGICAL INTERVENTION WAS REQUIRED TO TREAT THE REPLACE THE AORTIC VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE TILL THE EMBOLIZATION, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE IMPLANTER BELIEVE WAS THE CAUSE OF MIGRATION DUE TO EXCESSIVE CALCIUM. THE PATIENT'S STATUS WAS RECOVERING.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24475566 ↗
• InjuryFeb 17, 2026Migration or Expulsion of Device

  CLINICAL INFORMATION: (B)(4) - ENVISION IDE STUDY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THERE WAS SUFFICIENT AMOUNT OF CALCIUM PRESENT (1880) TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. THE PATIENT'S AORTIC VALVE ANGLE (AV ANGLE FROM 3MENSIO) WAS ABOUT 50 DEGREES. THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WERE 671 MM2 AND PERIMETER 93MM. DURING PROCEDURE, THE ACTIVATED CLOTTING LEVELS WERE 400S AND HEPARIN WAS GIVEN. A PRE-IMPLANT BALLOON VALVULOPLASTY WAS DONE WITH A 28MM NON-ABBOTT BALLOON. THE FINAL IMPLANT DEPTH AT LEFT CORONARY CUSP (LCC) WAS 4.5MM. AFTER FULL VALVE DEPLOYMENT, THE VALVE NOTED TO HAVE MIGRATED TOWARDS AORTA. THE IMPLANTER BELIEVED THE CAUSE OF MIGRATION WAS INSUFFICIENT ANCHORING. THE PATIENT WAS REPORTED STABLE BUT THE VALVE WAS NOT IN AN ACCEPTABLE POSITION AND THE GRADIENT WAS HIGH. THEY DECIDED TO IMPLANT A SECOND VALVE. ANEW NON-ABBOTT VALVE WAS CHOSEN AND COMPETED THE PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369020 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). BASELINE WAS SINUS BRADYCARDIA, WITH OCCASIONAL DROPPED BEATS. THE LENGTH OF THE MEMBRANOUS SEPTUM WAS 6.4MM. 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 WENT INTO A COMPLETE HEART BLOCK, AND IT WAS CHARACTERIZED TO BE INTERMITTENT. A TEMPORARY PACEMAKER WAS PLACED TO START THE PROCEDURE. DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 6MM ON THE NON-CORONARY CUSP (NCC) AND 5MM ON THE LEFT-CORONARY CUSP (LCC). A TEMPORARY PACEMAKER WAS LEFT IN PLACE TO STABILIZE THE CARDIAC RHYTHM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. ON AN UNKNOWN DATE IN (B)(6) 2026, THE PATIENT RECEIVED A PERMANENT PACEMAKER. THE IMPLANTER CLASSIFIES THIS EVENT AS BEING RELATED TO THE PATIENT¿S PAST MEDICAL HISTORY. THE PATIENT WAS IN A STABLE CONDITION AND NOTED TO BE DISCHARGED.

  Patient problems: Heart Block

  MAUDE report 24338762 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING AN UNKNOWN BALLOON, AND IT WAS NOTED THAT THE BALLOON WAS EMBOLIZED DURING INFLATION. DURING THE PREPARATION, VALVE CHECK REVEALED MISLOADING OF THE DEVICE. A NEW 35MM, NAVITOR VALVE AND DS WERE PREPARED. DURING THE PROCEDURE, ON THE INITIAL ATTEMPT, THE VALVE WAS NOT STABLE, SO A RECAPTURE WAS PERFORMED; ON THE SECOND ATTEMPT, THE VALVE WAS POSITIONED AT A HIGHER DEPTH, SO IT WAS RECAPTURED AGAIN. ON THE THIRD ATTEMPT, THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 6MM ON THE NON-CORONARY CUSP (NCC) AND 2MM ON THE LEFT-CORONARY CUSP (LCC). THE PATIENT BECAME HYPOTENSIVE AND WAS SUPPORTED BY MEDICATIONS TO MAINTAIN ADEQUATE HEMODYNAMICS. POST-IMPLANT LESS THAN 24 HOURS, THE PATIENT HAD BLURRED VISION AND GAIT DISTURBANCE, AND IT WAS CONFIRMED THAT THE PATIENT HAD A STROKE. NO INTERVENTIONS WERE PERFORMED SINCE THE PATIENT WAS OUTSIDE THE WINDOW FOR THROMBOLYTICS. THE PATIENT HAD AN EXTENDED HOSPITALIZATION. THE PHYSICIAN BELIEVES THAT THE DEPLOYMENT DIFFICULTIES WERE LIKELY AT

  Patient problems: Blurred Vision; Low Blood Pressure/ Hypotension; Movement Disorder; Stroke/CVA

  MAUDE report 24338760 ↗
• InjuryFeb 13, 2026Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM 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 25MM, UNKNOWN BALLOON. IT WAS NOTED THAT THE PRE-BAV WAS PERFORMED WITH A BALLOON NOT LESS THAN OR EQUAL TO THE MINIMUM ANNULUS DIAMETER. DURING THE PROCEDURE, AT FIRST ATTEMPT, THE VALVE NOTED TO HAVE AN INCOMPLETE STENT OPENING (ISO) WAS OBSERVED AND A RECAPTURE WAS PERFORMED. AT THE SECOND DEPLOYMENT, IT WAS REPORTED TO BE BADLY OPENED WITH A PALMITO SHAPED, AND THE VALVE WAS IMPLANTED. POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (POST-BAV) WAS PERFORMED USING A 28MM, NON-ABBOTT BALLOON. A 29MM NON-ABBOTT VALVE WAS IMPLANTED TO CIRCULARIZE THE STENT, FUNCTIONALLY AND HEMODYNAMICALLY GOOD RESULT WITH NO POST-PROCEDURE COMPLICATIONS FOR THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338675 ↗

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-0495-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
• Z-0493-2025 · Oct 17, 2024 · Open, Classified
  Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
• Z-0492-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
• Z-0494-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile