Navitor™ NVRO-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 05415067045805), received between Apr 18, 2024 and Sep 28, 2026 — classified as 11 deaths, 120 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (21 reports).

5 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Block

  MAUDE report 50923782 ↗
• InjurySep 24, 2026Difficult to Fold, Unfold or Collapse; Incomplete Coaptation; Intravalvular regurgitation

  It was reported that on (b)(6) 2026, a 23mm Navitor Vision valve was selected for implant using a small FlexNav Delivery System (DS). Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 20mm, non-Abbott balloon. During the procedure, an incomplete stent opening (ISO) was observed but able to be mitigated as per the established steps. The valve was able to be implanted successfully without complications at a depth of 3mm on the non-coronary cusp (NCC). Post-implant, mild paravalvular leak (PVL) was noted. Post-implant Balloon Aortic Valvuloplasty (post-BAV) was performed by using a 23mm, non-Abbott balloon with an additional 2ml inflation to optimize prosthesis expansion and correct the PVL. Post-procedure, Transthoracic echocardiographic (TTE) evaluation showed significant central aortic regurgitation, confirming prosthetic valve dysfunction with reported leaflet inactivity and hemodynamic instability characterized by alternating hypertension and hypotension. A second 23mm, Navitor Vision valve was implanted within the index valve. Final echocardiogram assessment showed absence of central regurgitation and PVL. No clinically significant delay occurred, no pr

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

  MAUDE report 50887932 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Block

  MAUDE report 50875621 ↗
• InjurySep 23, 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 23mm Navitor Vision Valve was chosen for implant using a Small FlexNav Delivery System for a valve-in-valve. The final implant depth at non-coronary cusp (NCC) was unknown and left coronary cusp (LCC) was unknown. On (b)(6) 2026, the patient presented to the emergency room stating that they were experiencing weakness in the right lower extremity since (b)(6) 2026. EKG and labs did not show any evidence of acute ischemia and no alarming values from baseline. Patient had significantly improved the following day. An MRI was performed and showed small area of acute ischemia left parietal, right frontal cerebellum. Patient is in stable condition and was discharged from the hospital on (b)(6) 2026.

  Patient problems: Stroke/CVA

  MAUDE report 50863876 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Block

  MAUDE report 50848465 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  (b)(4) VISTA Nova, Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 23mm Navitor with Radiopaque Markers was chosen for implant. The length of the membranous septum was 4.6mm. There was no calcification extending beneath the aortic annular plane in the interventricular septum. While in the Cusp Overlap View (COV), the inflow edge of the constrained valve within the capsule was positioned at the base of aortic annulus while the pigtail positioned was confirmed to be at the bottom of the non-coronary cusp (NCC). The final implant depth from the NCC to the ventricular end of the frame was 3.0mm. It was reported post-procedure, patient experienced complete heart block on (b)(6) 2026. A decision was made to continue temporary pacing while monitoring the clinical course. Prolonged hospitalization was reported due to monitoring of rhythm before discharge on (b)(6) 2026. As heart block persisted, a permanent pacemaker was implanted on (b)(6) 2026.

  Patient problems: Heart Block

  MAUDE report 50822815 ↗
• MalfunctionSep 18, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2026, a 23 Navitor Vision valve was selected for implant using a small FlexNav Delivery System (DS) due to the patient's anatomy with severely calcified aortic valve with tapered Left Ventricular Outflow Tract (LVOT) and smaller Sinus of Valsalva (SOV). Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using an 18mm, non-Abbott balloon. The valve was loaded and check with X-Ray. During the procedure, the physicians used rotation move to make insertion swifter and some resistance was experienced with the FlexNav DS. At 80 percent, the valve appeared to be constrained therefore a partial resheath was performed and it was observed that the nose cone was not recaptured completely. On the second attempt, the valve expanded comparatively better but significant paravalvular leak (PVL) was observed then the physician's deemed that the 23mm valve to be undersized and a second 25mm, Navitor Vision valve was decided to be replaced using a new small FlexNav DS. Once the loading was completed, 23mm, Navitor Vision valve was attempted for recapture but once again the retraction issue persisted while the nose cone being exposed. DS was retracted in

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818688 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 23 mm Navitor Vision Valve was selected for implant using a Small FlexNav Delivery System. The length of the membranous septum was reported to be 1.9 mm. No calcification was confirmed from the annulus to the subvalvular left ventricular outflow tract (LVOT). During the procedure, complete atrioventricular block (CAVB) developed following deployment of the valve. A temporary pacemaker was subsequently placed, and the patient was transferred from the procedure room with the temporary pacemaker in place. The final implant depth of the Navitor valve was reported as 3 mm at the non-coronary cusp (NCC) and 5 mm at the left coronary cusp (LCC). The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay. Post-operative monitoring was performed. The patient recovered from CAVB the following day, however; CAVB recurred and a permanent pacemaker was subsequently implanted. As the patient had a short membranous septum (MS), the implanter believed that the event was related to either wire manipulation during the procedure or the position of the valve. The patient's status at the time of reporting was

  Patient problems: Heart Block

  MAUDE report 50801528 ↗
• InjurySep 4, 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 23mm Navitor Vision Valve was chosen for implant using a Small FlexNav Delivery System. A pre-implant balloon valvuloplasty was done with a 18mm non-Abbott balloon. The valve got partially re-sheathed 1 time due to the implant being too high. The final implant depth at non-coronary cusp (NCC) was 4.22mm and left coronary cusp (LCC) was 7.05mm. The patient developed a left bundle branch block (LBBB) during the procedure. No treatment was required. The patient was then discharged from the hospital on (b)(6) 2025.

  Patient problems: Heart Block

  MAUDE report 50620271 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Information: CRD_1066 - Envision IDE Study, Patient Site (b)(6) - (b)(6).It was reported that on (b)(6) 2026, a 23mm Navitor Vision Valve was chosen for implant using a Small FlexNav Delivery System. A pre-implant balloon valvuloplasty was done with a 18mm non-Abbott balloon. The final implant depth at non-coronary cusp (NCC) was 1.7mm and left coronary cusp (LCC) was 4.2mm. The patient developed a left bundle branch block (LBBB) during the procedure. A temporary pacemaker was implanted. The pacemaker was removed on (b)(6) 2026 and the patient was then discharged from the hospital on (b)(6) 2026.

  Patient problems: Heart Block

  MAUDE report 50533251 ↗
• InjuryAug 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) 2025, a 23mm Navitor Vision Valve was chosen for implant using a Small FlexNav Delivery System. A pre-implant balloon valvuloplasty was done with a 20mm non-Abbott balloon. The final implant depth at non-coronary cusp (NCC) was 3.95mm and left coronary cusp (LCC) was 4.66mm. The patient developed a left bundle branch block (LBBB) post-procedure and experienced multiple elevated blood pressure measurements. Hydralazine was administered to treat the hypertension. The patient was then discharged the following day. On (b)(6) 2025, junctional rhythm was noted. No additional treatment was required.

  Patient problems: Arrhythmia; Heart Block; High Blood Pressure/ Hypertension

  MAUDE report 50477011 ↗
• MalfunctionAug 21, 2026Difficult to Fold, Unfold or Collapse; Perivalvular Leak

  It was reported that on (b)(6) 2026, a 23mm Navitor Vision valve was selected for implant using a small FlexNav Delivery System (DS). Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 20mm, non-Abbott balloon. During the procedure, an incomplete stent opening (ISO) was observed and a recapture was performed and the ISO was reportedly mitigated. The valve was able to be implanted successfully at a depth of 6mm both on the non-coronary cusp (NCC) and left-coronary cusp (LCC). The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. Post-procedure less than 48 hours, moderate paravalvular leak (PVL) was observed. Post-implant Balloon Aortic Valvuloplasty (post-BAV) was performed by using a 20mm, non-Abbott balloon. Moderate PVL remained unchanged. The user believes the non-uniform expansion was caused by calcification. The patient's condition is unknown.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50371597 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Information: CRD (b)(4) - Envision IDE Study, Patient Site (b)(6) .It was reported that on (b)(6) 2026, a 23mm Navitor Vision Valve was chosen for implant using a Small FlexNav Delivery System for a valve-in-valve procedure. The final implant depth at non-coronary cusp (NCC) was 3.4mm and left coronary cusp (LCC) was 3.2mm. Post-procedure, the patient developed a 5.5 second pause with non-conducted P wave with progressive R-R interval lengthening prior to the pause marked by sudden flowing of heart rate. No treatment was required. The cardiac arrhythmia was resolved without sequelae on the following day. The patient was discharged from the hospital on (b)(6) 2026.

  Patient problems: Arrhythmia

  MAUDE report 50260492 ↗
• InjuryAug 11, 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 23mm Navitor Vision Valve was chosen for implant using a Small FlexNav Delivery System. A pre-implant balloon valvuloplasty was done with a 20mm non-Abbott balloon. The valve got partially re-sheathed 1 time due to the implant being too high. The final implant depth at non-coronary cusp (NCC) was 3.4mm and left coronary cusp (LCC) was 5.8mm. Immediately upon corssing the valve and placing the catheter within the ventricle, the patient developed a complete heart block and required pacing. A temporary balloon tip pacemaker was placed. Post-procedure, the patint was in sinus brady with atrioventricular dissociation. The patient was placed on norepinephrine, midodrine, and hydrocortisone. The following day, the patient received a permanent pacemaker. On (b)(6) 2026, the patient was discharged from the hospital.

  Patient problems: Bradycardia; Heart Block; Low Blood Pressure/ Hypotension

  MAUDE report 50214070 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 23mm Navitor Vision valve was selected for implant using a small FlexNav Delivery System (DS). The patient has a prior medication history of 30 mg, Lixiana® (edoxaban). Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 23mm, non-Abbott balloon. Upon insertion of 260cm, spring wire (non-Abbott brand, J-tip) into the left ventricle, the patient's blood pressure became low, and an unclear Percutaneous Cardiopulmonary Support (PCPS) was performed. During the procedure, the valve was able to be implanted. Post-implant, aortic root rupture and a type B dissection had occurred; small amount of circumferential pericardial effusion was observed to be at the apex of heart. Pericardiocentesis was attempted to resolve the event. However, the procedure was aborted because the amount of pericardial effusion was minimal, and further puncture was considered too risky. ECMO (Extracorporeal Membrane Oxygenation) was subsequently initiated. The physician(s) concluded the presence of cardiac tamponade. The user believed the cause of pericardial effusion to be due to the 23mm, non-Abbott balloon. ECMO has been discontinued; however, the p

  Patient problems: Cardiac Tamponade; Pericardial Effusion; Vascular Dissection

  MAUDE report 50181062 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  (b)(4) VISTA Nova, Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 23mm Navitor with Radiopaque Markers was chosen for implant. Following deployment of the 23mm Navitor Valve, patient had complete atrioventicular block, subsequently requiring placement of a temporary pacemaker via left femoral venous access. Post-implant, it was also reported there was difficulty achieving hemostasis at primary vascular access site. Three Perclose closure devices and one 8F Angioseal were used to address femoral access site closure.

  Patient problems: Heart Block

  MAUDE report 50018778 ↗
• DeathJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2026 a 23mm Navitor Vision Valve was selected for implant. During the procedure, when the device was deployed at 80% the patient went into atrial fibrillation several times. Cardioversion was performed to stabilize the patient, and the device was partially re-sheathed and re-positioned. The device was implanted. The final implant depth was 3mm from the non-coronary cusp (NCC). Post-implant the patient went into several cardiac arrests. It was noted that the left coronary artery was low with a height of 10mm. A stent was implanted to slow flow. Cardioversion, cardio massage, and atropine and anocoron were administered. However, after the sixth cardiac arrest, the patient passed away. The cause of death was determined to be the occlusion of the left coronary artery.

  Patient problems: Atrial Fibrillation; Cardiac Arrest

  MAUDE report 50009914 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 23mm Navitor Vision Valve was chosen for a procedure using a Small FlexNav Delivery System. The patient had previously implanted 19mm non-Abbott valve. During procedure, a pre-dilation was performed with a 20mm non-Abbott balloon. After the implant, an Aortic Stenosis was noted and a Valve-In-Valve procedure was performed. There was no delay in the procedure. The patient was reported stable.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25896065 ↗
• InjuryJul 10, 2026Difficult to Fold, Unfold or Collapse; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, A 23MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED BY USING A 20MM, NON-ABBOTT BALLON. DURING THE PROCEDURE, AN INCOMPLETE STENT OPENING (ISO) WAS OBSERVED AND WAS RESOLVED AFTER TWO RECAPTURES THEN 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). POST-IMPLANT, MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED. POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (POST-BAV) WAS PERFORMED BY USING A 20MM, NON-ABBOTT BALLOON. MILD PVL WAS OBSERVED.; THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. IT WAS ALSO REPORTED THAT HEMOSTASIS COULD NOT BE ACHIEVED USING PERCLOSE AND WAS ABLE TO BE ACHIEVED BY SURGICAL CUTDOWN. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25785721 ↗
• DeathJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 23 MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A FLEXNAV DELIVERY SYSTEM (DS). DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED. POST-PROCEDURE ONE MONTH LATER, THE PATIENT STARTED SHOWING SYMPTOMS OF A STAPHYLOCOCCAL INFECTION, WHICH WAS SUBSEQUENTLY CONFIRMED TO BE PRESENT AROUND THE AORTIC, MITRAL, AND TRICUSPID VALVES. MEDICATION WAS ADMINISTERED AND AN OPEN-HEART SURGERY WERE PERFORMED AS AN INTERVENTION TO TREAT THE EVENT. THE PATIENT ALSO HAD AN EXTENDED HOSPITALIZATION. ON AN UNKNOWN DATE, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WERE INFECTIONS. THE IMPLANTER CLASSIFIED THIS EVENT AS BEING RELATED TO THE PROCEDURE AND PATIENT¿S PAST MEDICAL HISTORY.

  Patient problems: Unspecified Infection

  MAUDE report 25692352 ↗
• InjuryJul 1, 2026Difficult to Fold, Unfold or Collapse; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, A 23 MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANTATION USING A SMALL FLEXNAV DELIVERY SYSTEM. THE NATIVE ANNULUS MEASUREMENTS WERE REPORTED AS 20.6 IN DIAMETER AND 64.7 IN PERIMETER. DURING THE PROCEDURE, HEPARIN WAS ADMINISTERED (DOSE UNKNOWN), AND THE ACTIVATED CLOTTING TIME (ACT) WAS MAINTAINED AT >250. AFTER THE NON-ABBOTT GUIDEWIRE PASSED THROUGH THE ANNULUS, THE GUIDEWIRE TWISTED WITHIN THE VENTRICLE. AT THAT TIME, THE PHYSICIAN SUSPECTED A PERICARDIAL EFFUSION (PE). A TRANSESOPHAGEAL ECHOCARDIOGRAM (TTE) WAS PERFORMED; HOWEVER, NO PE WAS VISIBLE AT THAT TIME. PRE-DILATATION WAS SUBSEQUENTLY PERFORMED, FOLLOWED BY VALVE IMPLANTATION AND POST-DILATATION. POST-DILATATION WAS PERFORMED DUE TO PERIVALVULAR LEAK (PVL) AND VALVE UNDEREXPANSION. THERE WERE NO REPORTED DIFFICULTIES DURING IMPLANTATION, NO MULTIPLE MANIPULATIONS, NO MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES, AND THE VALVE WAS NOT RE-SHEATHED MORE THAN TWO TIMES. AFTER FULL RELEASE OF THE NAVITOR VALVE, A PERICARDIAL EFFUSION WAS NOTED VIA TTE. THE EFFUSION WAS DESCRIBED AS CIRCUMFERENTIAL, WITH A LARGEST REPORTED VOLUME OF 400 ML. NO CARDIAC TAMPONADE WAS PRESENT. AT THE TIME

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 25680567 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  CRD_1059 - VISTA NOVA, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2026, A 23MM NAVITOR WITH RADIOPAQUE MARKERS WAS CHOSEN FOR IMPLANT. POST-PROCEDURE, AN ELECTROCARDIOGRAM NOTED COMPLETE ATRIAL BLOCK. A PERMANENT PACEMAKER WAS IMPLANTED ON (B)(6) 2026.

  Patient problems: Heart Block

  MAUDE report 25599455 ↗
• InjuryJun 3, 2026Perivalvular Leak

  CRD_1059 - VISTA NOVA, PATIENT SITE ID: (B)(6) (B)(4) IT WAS REPORTED THAT ON (B)(6) 2026, A 23MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT. PRE-IMPLANT BALLOON VALVULOPLASTY WAS PERFORMED WITH AN 18MM NON-ABBOTT BALLOON. DURING PROCEDURE, WHILE IN THE CUSP OVERLAP VIEW (COV), THE INFLOW EDGE OF THE CONSTRAINED VALVE WITHIN THE CAPSULE WAS POSITIONED AT THE BASE OF AORTIC ANNULUS WHILE THE PIGTAIL POSITIONED WAS CONFIRMED TO BE AT THE BOTTOM OF THE NON-CORONARY CUSP (NCC). IT WAS NOTED THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. THE IMPLANTING PHYSICIAN CHECKED FOR NON-UNIFORM EXPANSION PRIOR TO DEPLOYMENT. THE NAVITOR VALVE WAS NOT RESHEATHED DURING PROCEDURE BEFORE FINAL IMPLANT DEPTH OF 3.5MM BETWEEN THE INTRAVENTRICULAR END OF THE VALVE TO THE NCC. A POST-IMPLANT BALLOON VALVULOPLASTY WITH A 20MM NON-ABBOTT BALLOON WAS PERFORMED TO REDUCE MILD PARAVALVULAR LEAK TO NONE. POST-PROCEDURE BUT PRIOR TO DISCHARGE ON (B)(6) 2026, THE PATIENT EXPERIENCED LEFT BUNDLE BRANCH BLOCK (LBBB). NO TREATMENT WAS REPORTED. PATIENT STATUS WAS REPORTED STABLE.

  Patient problems: Heart Block

  MAUDE report 25382907 ↗
• InjuryMay 29, 2026Difficult to Fold, Unfold or Collapse; Perivalvular Leak; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6). 2026, A 23MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAS A PRIOR MEDICAL HISTORY OF BEING IMPLANTED WITH A 21MM, NON-ABBOTT SURGICAL VALVE WHICH IS NOW DEGENERATED. PRE-IMPLANT BALLOON 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 3.5MM ON THE NON-CORONARY CUSP (NCC). AN INCOMPLETE STENT OPENING (ISO) WAS OBSERVED; POST-IMPLANT, PARAVALVULAR LEAK (PVL) WAS OBSERVED. POST-IMPLANT BALLOON VALVULOPLASTY (POST-BAV) WAS PERFORMED USING A 22MM, NON-ABBOTT BALLOON FOR AN UNKNOWN REASON. NO PARAVALVULAR LEAK (PVL) WAS OBSERVED; MEAN GRADIENT WAS 12MMHG. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25333993 ↗
• InjuryMay 1, 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) 2025, A 23MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE FINAL IMPLANT DEPTH AT NON-CORONARY CUSP (NCC) WAS 2.9MM AND LEFT CORONARY CUSP (LCC) WAS 3.1MM. THE PATIENT DEVELOPED A LEFT BUNDLE BRANCH BLOCK (LBBB) AND AN EPISODE OF NOCTURNAL HYPERTENSION POST-PROCEDURE. NO TREATMENT WAS REQUIRED FOR THE LBBB AS IT WAS RESOLVED THE FOLLOWING DAY. ALDACTONE WAS ADMINISTERED TO TREAT THE HYPERTENSION. ON 04 JULY 2025, THE PATIENT EXPERIENCED PALPITATION AND EPIGASTRIC PAIN AND THE METOPROLOL DOSE WAS DECREASED.

  Patient problems: Arrhythmia; Heart Block; High Blood Pressure/ Hypertension

  MAUDE report 25060118 ↗

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