Navitor™ NVRO-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 385 adverse event reports that list this exact device (DI 05415067045782), received between Dec 14, 2023 and Sep 29, 2026 — classified as 32 deaths, 316 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (64 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 385 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Arrhythmia

  MAUDE report 50937985 ↗
• InjurySep 29, 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 25mm 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 fully re-sheathed 1 time due to the implant being too high. The final implant depth at non-coronary cusp (NCC) was 3.9mm and left coronary cusp (LCC) was 4.8mm. The patient developed a left bundle branch block (LBBB) during the procedure. No treatment was required. The patient was then discharged from the hospital the following day.Subsequent information received:It was reported that on (b)(6) 2026, the patient returned for the 30 day follow-up and a new onset atrial fibrillation was noted. For treatment, the patient started Eliquis.

  Patient problems: Arrhythmia; Heart Block

  MAUDE report 50937892 ↗
• MalfunctionSep 28, 2026Difficult to Fold, Unfold or Collapse; Perivalvular Leak

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50926454 ↗
• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Information: (b)(6), Patient Site (b)(6) - (b)(4).It was reported that on (b)(6)2026, a 25mm Navitor Vision Valve was chosen for implant using a Small 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 4.8mm and left coronary cusp (LCC) was 5.6mm. The patient was then discharged from the hospital the following day. On (b)(6) 2026, the patient passed away due to an unknown cause. The patient developed dyspnea and lost consciousness. Cardiopulmonary resuscitation (CPR) was performed. The patient was resuscitated for 20 minutes with no success. The passing of the patient was unexpected. The patient was feeling better after the procedure and condition was improving. No further medical examination took place.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924055 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Block; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50902581 ↗
• InjurySep 24, 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 that on (b)(6) 2026, a 25mm Navitor Vision valve was selected for implant using a small FlexNav Delivery System (DS). During the preparation, loading was not successful as while passing the valve through the DS, the tip of the valve does not expand uniformly, causing the struts to overlap. After multiple attempts, this situation remained unchanged so a new 25mm, Navitor Vision was replaced resulting in successful implantation without any complications. The patient was in a stable condition.It was reported through the THT registry from Japan that on (b)(6) 2026, a 25mm Navitor Vision Valve was implanted. On (b)(6) 2026, the patient experienced severe conduction disturbance and required a pacemaker implant.

  Patient problems: Arrhythmia

  MAUDE report 50890119 ↗
• MalfunctionSep 21, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848469 ↗
• InjurySep 18, 2026Perivalvular Leak

  Clinical Information: (b)(4) - Envision IDE Study, Patient Site (b)(6).It was reported that on (b)(6) 2026, a 25mm Navitor Vision Valve was chosen for implant using a Small 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 3.46mm and left coronary cusp (LCC) was 7.43mm. The patient was discharged from the hospital the following day. On (b)(6) 2026, the 30 days TTE noted a moderate paravalvular leak. No treatment was required.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50828044 ↗
• InjurySep 18, 2026Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 25mm Navitor Vision valve was selected for implant using a large 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 patient has a severely calcified leaflets with calcification extending in the Left Ventricular Outflow Tract (LVOT). The patient's aortic valve angle was 52 degrees. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 20mm, non-Abbott balloon. During the procedure, while advancement of the FlexNav DS across the annulus, the patient developed with a complete Atrioventricular (AV) block. A temporary pacemaker was placed to stabilize the cardiac rhythm. At 80 percent deployment, an incomplete stent opening (ISO) was observed then the valve was recaptured. On the second attempt, the valve was placed at a depth of 4mm on the non-coronary cusp (NCC), ISO remained unchanged; however, it was full deployed in the native annulus at a depth of 4mm on the non-coronary cusp (NCC) and ISO was observed to be less than prior to deployment. Post-implant Balloon Aortic Valvuloplasty (post-BAV

  Patient problems: Heart Block; Movement Disorder; Stroke/CVA

  MAUDE report 50818971 ↗
• MalfunctionSep 18, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 25mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). The patient's aortic valve angle was measured to be 54 degrees. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 23mm, non-Abbott balloon. During the procedure, starting from stent inflow of the valve being position at the level of the non-coronary cusp (NCC) pigtail. Following inflow edge of Navitor valve 3mm below the pig tail; upon release, the valve had migrated 7mm into the ventricle. No second valve was required to be implanted. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The implanter believed the cause of migration to be due to the valve didn't have enough radial force. The patient was reportedly discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818616 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 25mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). During the procedure, the valve was able to be implanted successfully. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. Post-procedure within 2 hours, the patient showed minor symptoms (unspecified). Further evaluation from computed tomography (CT) and Magnetic Resonance Imaging (MRI) showed information of head. The patient had an extended hospitalization. The patient was discharged.

  Patient problems: Stroke/CVA

  MAUDE report 50818311 ↗
• MalfunctionSep 17, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2026, a 25 mm Navitor Vision Valve was selected for implant using a Small FlexNav Delivery System. During the procedure, it was reported that the valve was implanted too high at a final implant depth of 1 mm on the non-coronary cusp. A post-balloon aortic valvuloplasty was performed using a 22 mm non-Abbott balloon to address and resolve valve under expansion. It was reported that there were concerns that the valve would embolize. As a result, a second Small FlexNav Delivery System was opened in preparation for implantation of a second valve; however, a second valve was ultimately not required as the valve did not embolize. The delivery system was not used and was reportedly discarded at the site. The patient did not have any clinical signs or symptoms or experience any issues or adverse events during or after the procedure. There was no clinically significant delay, and the patient remained hemodynamically stable throughout the procedure. The user believed the valve expanded non-uniformly due to excess calcium. The patient's status was reported as stable and discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801535 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  (b)(6) - VISTA Nova, Patient Site ID: (b)(6). It was reported that on 03 August 2026, an unknown Navitor was selected for implant. The length of the membranous septum measured 5.3mm. 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). Approximately one week post-procedure, it was then reported that asymptomatic intermittent atrioventricular block was observed. Sinus rhythm was restored and a leadless pacemaker was implanted on 17 August 2026 as a backup measure due to upcoming scheduled non-cardiac surgery and risk of recurrent heart block. Prolonged hospitalization was reported for monitoring of cardiac rhythm. The patient status was reported discharged.

  Patient problems: Heart Block

  MAUDE report 50773906 ↗
• DeathSep 11, 2026Migration or Expulsion of Device; Off-Label Use

  It was reported that on (b)(6) 2026, a 25mm Navitor Valve with a Small FlexNav Delivery System were chosen for Off Label transcatheter aortic valve-in-valve procedure of a previously implanted 25mm Epic Plus Valve. During post-dilatation of the 25mm Navitor Valve with a 24mm non-Abbott balloon, it was noted there was a complication involving fracture of the 25mm Epic Plus Valve, and the 25mm Navitor Valve had migrated in the aortic direction, causing partial right and left coronary artery obstruction. The migrated valve was snared and repositioned to allow coronary access and placement of a new valve. Subsequently, a decision was made to prepare a second 25mm Navitor Valve with a second new Small FlexNav Delivery System that was successfully implanted within the 25mm Epic Plus Valve. The patient remained hemodynamically stable throughout the procedure. Post-operatively, patient suffered an ischemic stroke, which worsened over time, and ultimately leading to patient death on (b)(6) 2026.

  Patient problems: Coronary obstruction/occlusion; Stroke/CVA

  MAUDE report 50733844 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 25mm 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 less than 3mm. There was calcification extending beneath the aortic annular plane in the interventricular septum. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using an 18mm, non-Abbott balloon. The patient was developed with a complete heart block. During the procedure, the valve was able to be implanted at a depth of 0mm on the non-coronary cusp (NCC) and 3mm on the left-coronary cusp (LCC). An unspecified grade of paravalvular leak was observed and a post-implant Balloon Aortic Valvuloplasty (post-BAV) was performed by using a 20mm, non-Abbott balloon. 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. Post-procedure later that day, a permanent pacemaker was implanted to resolve the event. The patient was discharge

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Block

  MAUDE report 50417853 ↗
• InjuryAug 21, 2026Migration or Expulsion of Device; Perivalvular Leak; Off-Label Use

  It was reported that on (b)(6) 2026, a 25 mm Navitor Vision Valve was selected for a valve-in-valve procedure. The Navitor Valve was implanted within a 25 mm non-Abbott surgical aortic valve that had been implanted in 2015. No pre-dilation was performed. The patient's aortic valve angle was reported as 43 degrees. During the procedure, the implant depth at approximately 80% deployment was reported as 4 mm at the non-coronary cusp (NCC) and 4 mm at the left coronary cusp (LCC). The Navitor valve was successfully released; however, upon release, the non-marker side of the Navitor valve moved upward. Immediately prior to migration, the implant depth of the Navitor valve was reported as 2 mm below the 25 mm non-Abbott valve frame. It was clarified that the valve moved superiorly toward the aortic arch. The final implant depth after migration was reported as 0.0 mm at the non-coronary cusp (NCC) and 2.0 mm at the left coronary cusp (LCC). Moderate to severe paravalvular leak (PVL) was observed. The implanter checked for non-uniform expansion (NUE), and no NUE was observed. No eccentric calcification or anatomical/tissue-calcium interference affecting valve expansion was reported. Post-d

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50379123 ↗
• InjuryAug 18, 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 27mm Navitor Vision Valve was chosen for implant using a Large 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 5.64mm and left coronary cusp (LCC) was 6.29mm. The patient developed a left bundle branch block (LBBB) post deployment of the valve. No treatment was required. On (b)(6) 2026, the patient reported multiple episodes of nausea and vomiting. Symptoms were solves, but LBBB was still persistent. The patient was discharged from the hospital on (b)(6) 2026.

  Patient problems: Heart Block; Movement Disorder; Nausea

  MAUDE report 50309033 ↗
• DeathAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2026 a Navitor Vision was selected for implant. The device was implanted. Post-procedure the patient began deteriorating. Echocardiography showed the device was functioning properly. However, the patient passed away later that evening. The cause of death was unknown.

  Patient problems: Insufficient Information

  MAUDE report 50281952 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 25 mm Navitor Vision Valve was selected for implant using a Small FlexNav Delivery System (DS). The patient had a pre-existing first-degree atrioventricular (AV) block prior to the procedure. The length of the membranous septum was not measured. No calcification extending beneath the aortic annular plane in the interventricular septum was reported. During the procedure, while crossing the aorta with a non-Abbott guidewire (prior to the DS entering the patient's body) the patient developed complete heart block. As a result, pacing support was required during the procedure. 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). The valve was successfully implanted. The final implant depth at release was approximately 3 mm. Following the procedure, the patient remained in complete heart block and continued to require pacing support from a temporary pacemaker. A permanent pacemaker was implanted the following day. No prolonged hospital stay due to the adverse event was repo

  Patient problems: Heart Block

  MAUDE report 50261182 ↗
• InjuryAug 11, 2026Migration or Expulsion of Device

  It was reported that on (b)(6)2026, a 25 mm Navitor Vision Valve was selected for implant using a Small Navitor Loading System and a Small FlexNav Delivery System. During the procedure, pre-dilatation was performed using a 20 mm non-Abbott balloon. The balloon diameter did not exceed the minimum annular diameter. The native annular measurements were reported as an annulus perimeter of 62.1 mm, a perimeter-derived diameter of 22 mm, an annular area of 357.5 mm², and an LVOT measurement of 20.5 mm. In the user's opinion, there was sufficient calcium present to allow anchoring of the device, with a reported calcium score of approximately 1200. The patient's aortic valve angle was reported as RAO 7 / CRA 3 in 3-cusp view and RAO 30 / CAU 14 in alternative 2-cusp view. The implant depth at 80% deployment was reported as 2-3 mm. Prior to final deployment, the implanter reported that the delivery system was maintained in a neutral/slight forward-pressure position and that the guidewire was pulled to a mid-ventricular position to deflect the nosecone. All three tabs were reportedly confirmed released. After 80% deployment, the valve migrated during the final 10% of deployment and dove very

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209026 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Information: (b)(4) - Envision IDE Study, Patient Site (b)(6) - (R1012806701).It was reported that on (b)(6) 2026, a 25mm Navitor Vision Valve was chosen for implant using a Small FlexNav Delivery System. The final implant depth at non-coronary cusp (NCC) was 3.9mm and left coronary cusp (LCC) was 4.8mm. Post-procedure, the patient demonstrated atrial fibrillation. The degree of bradycardia was excessive and inappropriate. A permanent pacemaker was implanted on (b)(6) 2026 and the patient was discharged from the hospital, the following day.

  Patient problems: Atrial Fibrillation; Bradycardia

  MAUDE report 50180770 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  (b)(6) Patient Site ID: (b)(6).It was reported that on (b)(6) 2026, a 25mm Navitor with Radiopaque Markers was chosen for implant. After valve deployment, patient experienced left bundle branch block (LBBB) and first-degree atrioventricular block (AVB). No treatment or intervention was reported to treat LBBB and AVB. During hospitalization post-procedure but before discharge, patient experienced complete heart block on (b)(6) 2026. A decision was made to implant a permanent pacemaker the same day. It was reported that the event resolved without sequelae on (b)(6) 2026.

  Patient problems: Heart Block

  MAUDE report 50175973 ↗
• InjuryAug 4, 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 25mm Navitor Vision Valve was chosen for implant using a Small FlexNav Delivery System. The final implant depth at non-coronary cusp (NCC) was 4.78mm and left coronary cusp (LCC) was 4.69mm. Post-procedure, minor bleeding was noted at the right femoral access site. Manual compression and glue dressing were applied to resolve the bleeding. A small hematoma was observed at the right groin. On (b)(6) 2026, intermittent complete heart block with rapid ventricular escape rhythm was observed. On (b)(6) 2026, the patient received a permanent pacemaker and was discharged the following day.

  Patient problems: Heart Block

  MAUDE report 50135354 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Information: CRD_1066 - Envision IDE Study, Patient Site (b)(6)- (R1012343401)It was reported that on (b)(6)2026, a 25mm 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 2 times due to the implant being too low. During the procedure, the patient developed a complete heart block. The valve was implanted. The following day, the patient had prolonged PR 400MS and a left bundle branch block (LBBB). The patient received a permanent pacemaker on 03 July 2026 and was discharged the following day.

  Patient problems: Heart Block

  MAUDE report 50103950 ↗
• InjuryJul 27, 2026Patient-Device Incompatibility; Patient Device Interaction Problem

  Clinical Information: (b)(4) - Envision IDE Study, Patient Site (b)(6).It was reported that on (b)(6) 2026, a 25mm Navitor Vision Valve was chosen for implant using a Small 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 4.5mm and left coronary cusp (LCC) was 6.6mm. On (b)(6) 2026, the patient was in the hospital and imaging showed hypo-attenuated leaflet thickening was present. For treatment, the patient was prescribed Eliquis.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50024590 ↗

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-0492-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
• Z-0495-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
• Z-0491-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
• Z-0494-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile