NavitorRecalls & reported problems across all models

We found 9 models of Navitor by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 2,331 adverse event reports in the FDA's MAUDE database, received between Oct 20, 2021 and Sep 29, 2026 — classified as 184 deaths, 1,960 injuries, 187 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (455 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Navitor recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 17, 2024Open, 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-0495-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 17, 2024Open, 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 ↗

3. Oct 17, 2024Open, 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-0493-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Oct 17, 2024Open, Classified

   A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

   Z-0492-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Navitor problems

Navitor models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Navitor™ NVRO-27

  Aortic valve, prosthesis, percutaneously delivered
  1 recall35 deaths471 reports
• Navitor™ NVTR-27

  Aortic valve, prosthesis, percutaneously delivered
  1 recall27 deaths360 reports
• Navitor™ NVRO-25

  Aortic valve, prosthesis, percutaneously delivered
  32 deaths385 reports
• Navitor™ NVRO-29

  Aortic valve, prosthesis, percutaneously delivered
  1 recall19 deaths318 reports
• Navitor™ NVTR-29

  Aortic valve, prosthesis, percutaneously delivered
  1 recall28 deaths249 reports
• Navitor™ NVTR-25

  Aortic valve, prosthesis, percutaneously delivered
  21 deaths279 reports
• Navitor™ NVRO-23

  Aortic valve, prosthesis, percutaneously delivered
  11 deaths139 reports
• Navitor™ NVTR-23

  Aortic valve, prosthesis, percutaneously delivered
  11 deaths129 reports
• Navitor™ NVTR-LS-SM

  Aortic valve, prosthesis, percutaneously delivered
  1 report

Recent Navitor adverse event reports

The 15 most recent reports across all models, 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 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 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Block

  MAUDE report 50923782 ↗
• 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, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Aortic Valve Stenosis; Bradycardia; Heart Block

  MAUDE report 50902699 ↗
• InjurySep 25, 2026Off-Label Use

  Patient problems: Heart Block

  MAUDE report 50902651 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50902581 ↗
• 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, 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 ↗

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