Navitor™ NVRO-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 471 adverse event reports that list this exact device (DI 05415067045799), received between Dec 21, 2023 and Sep 29, 2026 — classified as 35 deaths, 401 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (85 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-0494-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 471 reports, in the reporter's own words as published by the FDA.

• DeathSep 29, 2026Patient-Device Incompatibility

  (b)(4), Patient Site ID: (b)(6). It was reported that on (b)(6) 2026, a 27mm Navitor with Radiopaque Markers was chosen for implant. Prior to procedure, patient's condition was reported stable. Post-procedure, it was reported patient experienced amnesia, persistent severe motor restlessness, and speech disorder. Neurology was consulted and computed tomography (CT) was performed on (b)(6) 2026. Findings concluded delineation of subacute infarct adjacent to pre-existing cortico-subcortical parenchymal defect in the left frontal region. Stroke symptoms lasted weeks. It was later reported on (b)(6) 2026, a Type A dissection was noted via transesophageal echocardiogram (TEE) extending into the right iliac arteries and common carotid artery with renal arteries originating from the true lumen. A CT confirmed Type A aortic dissection, starting from the distal to the sino-tubular junction, extending proximally into the left anterior interior chain (AIC), with extension into the brachiocephalic trunk and right carotids. Patient was administered medication. The physician attributed the cause of the Type A dissection due to the Navitor Valve. Patient was reported to have passed away on (b)(6)

  Patient problems: Cognitive Changes; Movement Disorder; Stroke/CVA; Vascular Dissection

  MAUDE report 50940679 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 27mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). The patient did not have a history of Right Bundle Branch Block (RBBB), Left Bundle Branch Block (LBBB) and 1st/2nd Atrioventricular Block (AV) block. The length of the membranous septum was 2.3mm. There was no calcification extending beneath the aortic annular plane in the interventricular septum. The patient had severely impaired Left Ventricle (LV) function. During the procedure, the valve was able to be implanted successfully at a depth of 5mm on the non-coronary cusp (NCC). Post-implant, the cardiac rhythm changed from sinus rhythm to ventricular tachycardia. The patient received one defibrillation shock to restore the rhythm. Due to the absence of cardiac output chest compressions were continued for approximately one-minute until blood pressure was restored. The physician mentioned that it was not related to the valve performance, but indeed likely related to the patient's past medical history. A temporary pacing wire was placed and remained in the hospital for observation. After a few days, the patient's rhythm recovered subsequently discharged.

  Patient problems: Tachycardia

  MAUDE report 50915422 ↗
• DeathSep 25, 2026Migration or Expulsion of Device

  It was reported on (b)(6) 2026 a 27mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System. The native valve was measured with a perimeter of 74.9mm and area of 435.9mm. The left ventricular outflow tract (LVOT) was measured 24.4mm. Thirteen thousand units of Heparin were administered. Pre-balloon aortic valvuloplasty was performed with a 23mm Non-Abbott Balloon. During the procedure, the valve popped out at approximately 45% deployment. The patient experienced some chest discomfort. The pigtail catheter was noted to be wrapped around the device. The pigtail was pulled back, and the valve was partially re-sheathed. A second deployment attempt was made at a deeper position per the physician's request. However, the valve popped out again at 45% deployment. A root angiogram was performed and revealed an aortic perforation. The patient then became hemodynamically unstable with low blood pressure and severe aortic regurgitation. To provide stabilization for transport to the operating room, the valve was fully deployed at a depth of 12mm on both the non-coronary cusp (NCC) and left coronary cusp (LCC). The patient then became unresponsive and was emergently

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion; Tachycardia

  MAUDE report 50903153 ↗
• DeathSep 25, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 27mm Navitor Vision Valve was chosen for implant using a Large FlexNav Delivery System. After the deployment of the valve, a pop-up was observed and an attempt to snare the valve was performed. However, during the attempt, an aortic dissection was observed. Causing the patient to pass away.

  Patient problems: Vascular Dissection

  MAUDE report 50902856 ↗
• InjurySep 25, 2026Off-Label Use

  Patient problems: Heart Block

  MAUDE report 50902651 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  Patient problems: Endocarditis

  MAUDE report 50899277 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  (b)(4) - VISTA Nova, Patient Site ID: (b)(6).It was reported that on 19 August 2026, a 27mm Navitor with Radiopaque Markers was chosen for implant. The final implant depth from the non-coronary cusp to the ventricular end of the frame was 7.5mm. Post-procedure, the monitor showed a third-degree atrioventricular block had occurred. A decision was made to implant a permanent pacemaker on (b)(6) 2026. Patient had preexisting anemia that became aggravated post-operatively. Patient was administered a blood transfusion on (b)(6) 2026.

  Patient problems: Anemia; Heart Block

  MAUDE report 50897638 ↗
• InjurySep 24, 2026Device Stenosis

  It was reported that on (b)(6) 2026, 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 by using a 22mm, non-Abbott balloon. During the procedure, the valve was able to be deployed without a recapture at a depth of 5mm on the non-coronary cusp (NCC). Post-procedure peak to peak gradient was measured to be 11mmHg. Post-implant Balloon Aortic Valvuloplasty (post-BAV) was performed by using a 24mm, non-Abbott balloon. During the closure process, the patient was developed with a localized pericardial effusion; cardiac tamponade and a pericardiocentesis (pericardial drainage) was performed to resolve the event. The patient's hemodynamic observed to have improved. No further bleeding was observed through the pericardial drainage procedure. At the end of procedure, the patient became hemodynamically stable. Post-procedure on the same day, the patient's condition was deteriorated and became unstable. The valve was explanted and replaced with an unspecified surgical valve. During the surgical procedure, it was identified that the cause to be due to the annular rupture. It was also

  Patient problems: Cardiac Tamponade; Pericardial Effusion; Transvalvular Pressure Gradient Increased

  MAUDE report 50888256 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 27mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). The patient did not have a history of Right Bundle Branch Block (RBBB), Left Bundle Branch Block (LBBB) and 1st/2nd Atrioventricular Block (AV) block. The length of the membranous septum was 2.5mm. During the valve deployment, the patient was developed with a complete atrioventricular block (CAVB). The valve was able to be implanted at a depth of 3mm both on the non-coronary cusp (NCC) and left-coronary cusp (LCC). Temporary pacemaker was placed to stabilize the cardiac rhythm. 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: Heart Block

  MAUDE report 50887605 ↗
• MalfunctionSep 23, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a (b)(6) Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). The patient's aortic valve angle was measured to be (b)(6). Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a (b)(6), non-Abbott balloon. During the procedure, on the first attempt, at 80 percent, the valve was positioned at a depth of (b)(6) on the non-coronary cusp (NCC) and (b)(6) on the left-coronary cusp (LCC) based on the contrast injections in both the cusp overlap views and a Left Anterior Oblique (LAO) view with parallax removed from the valve frame. The decision was made to proceed with a slow release of the valve with controlled pacing at 120 beats per minute and a slow release of the first 2 retainer tabs, the valve remained in a stable and acceptable position. Upon release of the 3rd tab from the DS valve capsule the valve embolized up (aortic) above the annular plane along the non-coronary cusp (NCC) side of the native valve while remaining below the annular plane of Left coronary cusp (LCC) in an acceptable position. The patient remained stable throughout this timeframe; transthoracic echocardiogram (TTE) results

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50863284 ↗
• InjurySep 22, 2026Perivalvular Leak; Poor Visibility

  It was reported that on (b)(6) 2026, a 27mm Navitor was chosen for implantation, utilizing a large FlexNav. The patient presented with severe aortic stenosis, atrial fibrillation, right bundle branch block (RBBB), and calcification was confirmed from the annulus to the subvalvular to left ventricular outflow tract (LVOT). It was noted that imaging difficulties occurred during the procedure. The valve was implanted at a depth of 4.6 mm on non-coronary cusp (NCC) and 3.3 mm on left coronary cusp (LCC). The procedure was completed.On (b)(6) 2026, the patient presented to the hospital with atrial fibrillation and symptomatic second-degree heart block. To treat the heart block, a permanent pacemaker was implanted on the same day.On (b)(6) 2026, an echocardiogram was performed and revealed mild paravalvular leak (PVL). The patient was reported to be stable and discharged to home. No additional information was provided.

  Patient problems: Heart Block

  MAUDE report 50859259 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 27mm Navitor was chosen for implantation, utilizing a large FlexNav delivery system. The patient presented with severe aortic stenosis. The 27mm Navitor valve was deployed without issues. However, on the same day, three hours following completion of the procedure, the patient developed neurological symptoms, and it was identified that the patient experienced a stroke. Imaging revealed a left anterior cerebral artery (ACA) stroke. It was noted that based on the patient¿s neurologic event and the treatments available at the facility, a decision was made to transfer the patient to another medical center for further evaluation and treatment. No additional information was provided.

  Patient problems: Stroke/CVA

  MAUDE report 50859255 ↗
• InjurySep 21, 2026Migration or Expulsion of Device; Off-Label Use

  It was reported that on (b)(6) 2026, a 27mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). The patient had a severely calcified bicuspid aortic valve. The procedural strategy consisted of implanting the valve approximately 2 mm below the annular plane, targeting skirt positioning at the annulus to minimize the risk of paravalvular leak (PVL). The procedure was performed in the cusp overlap projection. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 22mm, non-Abbott balloon. During the procedure, at 80 percent, angiographic confirmation was obtained in the left anterior oblique (LAO) projection with parallax correction for detailed assessment of valve position. The valve position was considered appropriate and consistent with the pre-established procedural strategy. Upon final release, the valve was at a depth of 2mm and able to be implanted. Post-implant, the valve had migrated towards the ascending aorta. The valve was repositioned using a snare and secured in a stable position within the aorta. A second 27mm, Navitor Vision valve was implanted by performing a valve-in-valve procedure to resolve the event resul

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847653 ↗
• 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 27mm Navitor with Radiopaque Markers was chosen for implant. 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 between the intraventricular end of the valve to the NCC was 4.5mm. Post-implant, a transient complete heart block occurred with a second episode had occurred in the recovery room. Prolonged intensive care unit (ICU) hospitalization was required for monitoring of cardiac rhythm due to temporary pacemaker dependance. A decision was made to implant a permanent pacemaker on (b)(6) 2026.

  Patient problems: Heart Block

  MAUDE report 50820406 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 27mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). The patient's aortic valve angle was 42 degrees. During the procedure, the valve was able to be implanted successfully without recapture. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. Post-procedure less than 48 hours, the patient was developed with left arm weakness and dysarthria. Computed tomography (CT) revealed M2 occlusion. Follow-up CT revealed left cerebellar and right external capsular infarcts. No interventions were performed and it was reported that the symptoms were improving. The patient had an extended hospitalization and subsequently discharged.

  Patient problems: Movement Disorder; Stroke/CVA

  MAUDE report 50819130 ↗
• InjurySep 18, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 27mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was not performed. During the procedure, on the first attempt, the valve was placed at a depth of 3mm on the non-coronary cusp (NCC) and it was able to be implanted approximately at a depth of 3mm. Mild paravalvular leak (PVL) was performed. Post-implant Balloon Aortic Valvuloplasty (post-BAV) was performed by using a 22mm, non-Abbott balloon. Aortogram was performed and upon removal of the pigtail, it got caught on the Navitor valve. Following, the physician pulled the pigtail catheter, Navitor valve had migrated to the ascending aorta. The valve was repositioned to a higher position in the ascending aorta using a snare to avoid coronary occlusion. A new 27mm, Navitor Vision valve was implanted at an optimal depth with no further issues by performing a valve-in-valve procedure. 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: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50818829 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Block

  MAUDE report 50782441 ↗
• InjurySep 11, 2026Perivalvular Leak; Adverse Event Without Identified Device or Use Problem

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Heart Block; Unspecified Infection

  MAUDE report 50740487 ↗
• DeathSep 11, 2026Perivalvular Leak; Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2026 a 27mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System. The patient was in sinus rhythm. Blood pressure was between 70mmHg and 100mmHg prior to the procedure. During the procedure it was noted that there was difficulty keeping the delivery system coaxial to the aorta due to the delivery system's inner curvature coming from the right subclavian access. The device was partially re-sheathed twice. The device was implanted. The final implant depth was 3mm from the non-coronary cusp (NCC) and 8mm from the left coronary cusp (LCC). A moderate perivalvular leak (PVL) was noted on the left side. The decision was made to implant a second device to address the PVL. A second 27mm Navitor Vision Valve was implanted at an implant depth of 0mm from the NCC and 5mm from the LCC. PVL improved to mild; however the patient remained hypotensive. On the same day the patient passed away.

  Patient problems: Insufficient Information

  MAUDE report 50737868 ↗
• InjurySep 9, 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 27mm Navitor Vision Valve was chosen for implant using a Large FlexNav Delivery System. A pre-implant balloon valvuloplasty was done with a 22mm non-Abbott balloon. The final implant depth at non-coronary cusp (NCC) was 3.6mm and left coronary cusp (LCC) was 5.7mm. During the testing of the pacing wires, the patient went into supraventricular tachycardia (SVT) and required cardioversion. Patient was back in normal sinus rhythm (NSR) post one shock. Post-procedure, the patient experienced weakness on the left side and garbled speech. A stat CT of the brain suggested embolic thrombus right cerebral artery. Plavix was started. On (b)(6) 2026, the patient was noted to be in accelerated junctional rhythm and a left bundle branch block was also noted on the ECG.

  Patient problems: Arrhythmia; Atrial Fibrillation; Heart Block; Stroke/CVA; Tachycardia

  MAUDE report 50697656 ↗
• DeathSep 4, 2026Adverse Event Without Identified Device or Use Problem

  This complaint consists of THT Registry data from Japan. 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) 2026, a 27mm Navitor Vision Valve was implanted. Following discharge, the baseline functional status was approximately NYHA Class III. Following an outpatient visit on (b)(6) 2026, the patient experienced shortness of breath and worsening heart failure. The patient then transferred hospital the following day. The heart failure exacerbation was considered mild. Congestion was not significant, elevated BNP levels and pleural effusion were observed. Human atrial natriuretic peptide (hANP) therapy was initiated for treatment. Additional diuretics were administered, resulting in improvement. Heart failure remained stable without oxygen support. On (b)(6) 2026, ventricular tachycardia and ventricular fibrillation occurred. Resuscitation was performed without success. The patient passed away on the same day.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Tachycardia; Ventricular Fibrillation

  MAUDE report 50620273 ↗
• 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) 2026, a 27mm 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 valve got fully and partially re-sheathed due to the implant being too high and too low. The final implant depth at non-coronary cusp (NCC) was 6.15mm and left coronary cusp (LCC) was 5.33mm. The patient developed a left bundle branch block (LBBB) after the third re-sheath and deployment of the valve. Post-procedure, a right bundle branch block (RBBB) was noted on EKG. The EKG on the following day noted a complete heart block and a permanent pacemaker was implanted. The patient was then discharged from the hospital on (b)(6) 2026.

  Patient problems: Heart Block

  MAUDE report 50620265 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Block; Heart Failure/Congestive Heart Failure

  MAUDE report 50572743 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Information: CRD_1059 - VISTA Nova Study, Patient Site ID: Site ID- (b)(6).It was reported that on (b)(6) 2026, a 27mm Navitor Vision Valve was chosen for implant using a Large FlexNav Delivery System. There wasn't calcification present extending beneath the aortic annular plane in the interventricular septum. The activated clotting levels were 183,189s and Heparin was given. A pre-implant balloon valvuloplasty (BAV) was done with a 20mm non-Abbott balloon. After pre-BAV, the patient had a left bundle branch block (LBBB). After multiple re-sheath (5 Full re-sheath) due to implant too low, the valve got removed and a new valve was used. A new 27mm Navitor Vision Valve and Large FlexNav Delivery System were chosen. The final implant depth was 5.03mm on non-coronary cusp (NCC) and 7.32mm at left coronary cusp (LCC). During hospitalization, patient experienced atrial fibrillation with bradycardia and LBBB. A decision was made to implant a temporary pacemaker on (b)(6) 2026. The patient was reported discharged.

  Patient problems: Atrial Fibrillation; Bradycardia; Heart Block

  MAUDE report 50371963 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 27 mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System. Pre-procedure, the patient was in normal sinus rhythm (NSR). The patient had no reported history of right bundle branch block (RBBB), left bundle branch block (LBBB), or first-/second-degree atrioventricular block. The membranous septum length was reported as less than 3 mm. No calcification extending beneath the aortic annular plane into the interventricular septum was reported. Access was obtained via the femoral approach. During the procedure, pre-dilation was performed using a 22 mm non-Abbott balloon. During loading, no issues were reported retracting the valve into the delivery system. No issues were reported leading the retainer tabs into the retainer receptacle. No increase in drag was noted on the deployment/re-sheath wheel during loading. While in the cusp overlap view (COV), the inflow edge of the constrained valve within the capsule was positioned at the base of the aortic annulus and the pigtail position was confirmed at the bottom of the non-coronary cusp (NCC). During 80% deployment, the valve would not stay in place and repeatedly slipped

  Patient problems: Heart Block

  MAUDE report 50261448 ↗

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-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
• 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