Navitor™ NVRO-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 318 adverse event reports that list this exact device (DI 05415067045775), received between Dec 11, 2023 and Sep 25, 2026 — classified as 19 deaths, 275 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (69 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-0493-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 318 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Aortic Valve Stenosis; Bradycardia; Heart Block

  MAUDE report 50902699 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision; Obstruction/Occlusion; Stroke/CVA

  MAUDE report 50848470 ↗
• InjurySep 18, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 29mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). The patient has a severely calcified native valve, and aortic valve angle was measured to be 61 degrees. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 24mm, non-Abbott balloon. During the procedure, DS was advanced through the transfemoral access and positioned in the native annulus as per the Instructions for Use (IFU). After achieving the desired implantation depth in cusp overlap view, an additional assessment was performed in Left Anterior Oblique (LAO) view to confirm central alignment of the DS. At 80 percent, the valve had appeared to be slightly deeper, and a partial recapture was performed. On the second attempt, the valve was positioned at a depth of approximately 4mm depth and confirmed in LAO view with parallax eliminated. Post-deployment, immediately the valve had migrated into the Left Ventricular Outflow Tract (LVOT). Two snares were used in an attempt to retrieve and reposition the valve. On both the occasions, the valve was successfully pulled back to an optimal position; however, it repeatedly migrated back i

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829364 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 29mm Navitor Vision Valve was chosen for implanted using a Large FlexNav Delivery System. During the deployment attempts, there were multiple recaptures due to horizontal root anatomy. The valve was two high twice and two low twice. At the beginning of procedure, the patient had a right bundle branch block and during the procedure, developed a total heart block. A temporary pacemaker was implanted.

  Patient problems: Heart Block

  MAUDE report 50823451 ↗
• DeathSep 18, 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 29mm Navitor Vision Valve was implanted. On (b)(6) 2026, the patient died due to a postoperative cerebral infarction.

  Patient problems: Stroke/CVA

  MAUDE report 50823043 ↗
• MalfunctionSep 18, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819529 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 29mm 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 length of the membranous septum was 2.8mm. There was no calcification extending beneath the aortic annular plane in the interventricular septum. Upon initiation of sedation, the patient was developed with bradycardia. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using an unspecified balloon subsequently developed with a complete atrioventricular block (CAVB). During the procedure, the valve was able to be implanted at a depth of 3mm on the non-coronary cusp (NCC) and 6mm on the left-coronary cusp (LCC) but the CAVB remained unchanged, and a temporary pacemaker was left in place. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The implanter classified this event as being related to the patient's past medical history. The patient was in a stable condition and subsequently discharged.

  Patient problems: Heart Block

  MAUDE report 50819378 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 29 mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System. It was reported that there was calcification extending beneath the aortic annular plane in the interventricular septum. During pre-balloon aortic valvuloplasty (BAV), the patient developed left bundle branch block (LBBB). A pacing wire was used during the procedure to pace the patient at 140-160 bpm. The valve was able to be successfully implanted with a final implant depth of 6 mm on the non-coronary cusp and 4 mm on the left-coronary cusp. There was no clinically significant delay. Overnight, the patient developed heart block. A permanent pacemaker was implanted to resolve the event. The patient required one additional day in the hospital. No additional intervention was needed. The implanter classifies this event as likely related to the procedure. The patient's status was reported as discharged.

  Patient problems: Heart Block

  MAUDE report 50819233 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Block

  MAUDE report 50740588 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 29mm 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 no calcification extending beneath the aortic annular plane in the interventricular septum. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 23mm, non-Abbott balloon. After the pre-BAV, the patient's rhythm was observed with premature ventricular contractions (PVCs). During the procedure, 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). The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. Post-implant, the patient went into a complete heart block, and a temporary pacemaker was placed to stabilize the event. On the following day, a permanent pacemaker was implanted to resolve the event. The patient had discharged, The implanter classified this event as being related to the

  Patient problems: Heart Block

  MAUDE report 50356587 ↗
• InjuryAug 18, 2026Migration or Expulsion of Device; Perivalvular Leak; Improper or Incorrect Procedure or Method

  It was reported that on (b)(6) 2026, a 29 mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System. The annular dimensions were reported as an annulus perimeter-derived diameter of 26.8 mm and an LVOT diameter of 26.2 mm. It was reported that there was sufficient calcium to allow anchoring of the device. During the procedure, pre-dilation was performed using a 24 mm non-Abbott balloon. The valve was recaptured more than two times because the implant position was considered too deep. Prior to final deployment, the implanter ensured that the delivery system was in a neutral position to slight forward pressure and pulled the guidewire to a mid-ventricular position to deflect the nose cone. The reported fluoroscopic projections were LAO 9/Cranial 4 and cusp overlap RAO 17/Caudal 19. At approximately 80% deployment, the implant depth was reported as 3 mm at the non-coronary cusp (NCC) and 4 mm at the left coronary cusp (LCC). The implanter confirmed that all three tabs had successfully released using two different views. The implant depth at release was reported as 3 mm at the NCC and 4 mm at the LCC. Following correct initial positioning and final release,

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50305563 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 29 mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System. The patient had a history of right bundle branch block (RBBB), which was also the patient's baseline rhythm prior to the procedure. The membranous septum length was 2.5 mm. It was reported that there was no calcification extending beneath the aortic annular plane into the interventricular septum. 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 initial implant depth was 3 mm; however, the valve was recaptured to achieve optimal depth on the left side. The final implant depth at release was 5 mm. A temporary pacemaker was used during the procedure, and the patient left the catheterization laboratory with the temporary pacemaker in place. Following the procedure, the patient's rhythm was reported to be similar, and the physician elected to observe the patient. The patient left the procedure room with RBBB, which was the same rhythm present prior to th

  Patient problems: Heart Block

  MAUDE report 50261359 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 29 mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System (DS). The patient had a history of right bundle branch block (RBBB). The membranous septum length was reported as 2.5 mm. No calcification extending beneath the aortic annular plane into the interventricular septum was reported. 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). During the procedure, the patient experienced heart block. The event occurred while the Large FlexNav DS was present within the patient's anatomy. The valve was able to be successfully implanted. The final implant depth at release was reported as 5 mm. A temporary pacemaker was utilized, and the patient left the catheterization laboratory with the temporary pacemaker in place. The patient remained hemodynamically stable throughout the TAVR procedure. No clinically significant delay was reported. The heart block persisted during the procedure and within 48 hours post-procedure. Moni

  Patient problems: Heart Block

  MAUDE report 50261353 ↗
• InjuryAug 13, 2026Perivalvular Leak

  It was reported that on (b)(6) 2026, a 29mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 24mm, unknown balloon. During the procedure, the valve repeatedly dived into the Left Ventricular Outflow Tract (LVOT) and it was at a deeper position on the left-coronary cusp (LCC). After two unsuccessful deployments, it was decided to replace with a new system. On the first attempt, the valve was able to be deployed at a depth of 3-4mm on the non-coronary cusp (NCC). Post-implant, mild paravalvular leak (PVL) was observed. Post-implant Balloon Aortic Valvuloplasty (post-BAV) was performed by using a 24mm, unknown balloon. Trace PVL was observed. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The patient was discharged.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50243941 ↗
• MalfunctionAug 11, 2026Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  It was reported that on (B)(6) 2026, a 29mm 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 24x40mm, non-Abbott balloon. During pre-BAV, the balloon slipped out of the annulus twice preventing optimal balloon positioning and expansion within the annulus. However, the physician considered the pre-BAV result to be sufficient and proceeded with the implantation of Navitor valve. During the procedure, on the first attempt, incomplete stent opening (ISO) was observed so the valve was recaptured. On the second attempt, ISO remained unchanged necessitating another recapture and decided to remove the valve from the patient's anatomy. Pre-BAV was performed once again, and it resulted in a satisfactory result. The physician decided to reuse the same valve despite the sales representative's recommendation. However, full stent opening was achieved, and the valve was able to be implanted successfully without the need of any additional recapturing at a depth of 5.2mm on the non-coronary cusp (NCC). The patient remained hemodynamically stable throughout the procedure and there was

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212673 ↗
• MalfunctionAug 7, 2026Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  It was reported that on (b)(6) 2026, a 29 mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System. During device preparation, no issues were reported with retracting the valve into the delivery system, leading the retainer tabs into the retainer receptacle, increased drag on the deployment/resheath wheel, or requiring excess force to turn the resheath wheel. The valve was loaded by a clinical engineer. During loading, the resheath/deploy wheel reached end of travel, and the gap was completely closed. At 80% deployment, the implanter switched to the LAO view and confirmed, with stent parallax removed, that the implant depth was not at an acceptable level below the annulus. Repeated recaptures were performed due to the horizontal anatomy and concerns regarding ISO findings and inappropriate implantation depth. The physician was reported to be aware of the IFU warning against resheathing more than two times. The user believed the non-uniform valve expansion was caused by severe calcification, resulting in incomplete valve expansion. The implanter evaluated the non-uniform expansion and performed mitigation according to established steps. During the fourt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181882 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6)2026, a 29 mm Navitor Vision Valve was selected for implant. The patient's relevant medical history included atrial fibrillation. Upon arrival to the procedure room, the patient had a conduction disturbance that appeared to be Mobitz II. During pre-balloon aortic valvuloplasty (pre-BAV), the patient developed complete heart block. A temporary pacemaker was utilized, and a permanent pacemaker was subsequently implanted. The healthcare professional stated that they did not believe the patient experienced adverse health consequences due to the performance of the product. The patient's status was reported as discharged.

  Patient problems: Heart Block

  MAUDE report 50181843 ↗
• InjuryAug 7, 2026Migration or Expulsion of Device; Perivalvular Leak

  It was reported that on (b)(6) 2026, a 29mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). The patient has a prior medical history of Atrial Fibrillation. The patient's aortic valve angle was 47 degrees. There was severe annulus calcification extending below annulus into Left Ventricular Outflow Tract (LVOT). Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 23mm, non-Abbott balloon. with a non-Abbott wire while pacing at 180 beats per minute. Post pre-BAV, the patient went into a complete heart block. During the procedure, DS's inflow edge was passed beyond the annulus then it was attempted to deploy. On the first attempt, it was positioned to be high, so it was recaptured. On the second attempt, the valve was placed at a depth of 4mm both on the non-coronary cusp (NCC) and left-coronary cusp (LCC). Upon release, the valve was at a depth of 3mm on the NCC and 4mm on the LCC. Temporary pacemaker was left in place at the end of the procedure to stabilize the rhythm. Post-implant, mild/moderate paravalvular leak was observed with a gradient of 2mmHg. Post-implant Balloon Aortic Valvuloplasty (post-BAV) was performed

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Block

  MAUDE report 50179574 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 29mm Navitor Vision Valve was chosen for a Transcatheter aortic valve replacement (TAVR) procedure. The length of the membranous septum was 6mm. There was no calcification present extending beneath the aortic annular plane in the interventricular septum. The final implant depth of the valve was 3mm. Post procedure, the patient needed a permanent pacemaker for complete heart block (CHB) after TAVR. The patient required prolonged hospital stay for monitoring of rhythm and the patient was reported discharged.

  Patient problems: Heart Block

  MAUDE report 50176906 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  (b)(4) - VISTA Nova, Patient Site ID: (b)(6) - 1732 (R1013130401).It was reported that on (b)(6) 2026, a 29mm Navitor with Radiopaque Markers was chosen for implant with a Large FlexNav Delivery System. After pre-dilatation, during implantation attempt, patient experienced third degree atrioventricular block. Post-implant of the 29mm Navitor Valve, a permanent pacemaker was implanted.

  Patient problems: Heart Block

  MAUDE report 50175028 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on 07 July 2026, a 29 mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System. The patient's relevant medical history included first-degree atrioventricular block and intermittent atrial fibrillation. The baseline rhythm was sinus rhythm with first-degree atrioventricular block. The membranous septum length was not measured. No calcification extending beneath the aortic annular plane into the interventricular septum was reported. 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 was confirmed to be at the bottom of the non-coronary cusp (NCC). At 80% deployment of the valve, the physician discontinued pacing and the patient was noted to have asystole. Pacing was subsequently resumed. The device was successfully implanted with a final implant depth of 5 mm at the NCC and 5 mm at the left coronary cusp (LCC). At the conclusion of the procedure, the patient left the procedure room with a right internal jugular (IJ) temporary pacemaker in place for overnight monitoring. Subsequently, a permanent pacem

  Patient problems: Cardiac Arrest

  MAUDE report 50105878 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Information: CRD_1066 - Envision IDE Study, Patient Site (b)(6) - (R1012220101).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 26mm 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 2.8mm and left coronary cusp (LCC) was 5.4mm. The patient developed a complete heart block during the procedure. A permanent pacemaker was implanted on (b)(6) 2026 and the patient was discharged on (b)(6)2026.

  Patient problems: Heart Block

  MAUDE report 50103949 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 29mm 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. There was no calcification extending beneath the aortic annular plane in the interventricular septum. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using 24mm, non-Abbott balloon. During pre-BAV, the patient was developed with heart block. During the procedure, the valve was able to be implanted at a depth of 4mm on the non-coronary cusp (NCC). The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. Post-procedure, a temporary pacemaker was placed to stabilize the event. A permanent pacemaker will be implanted. The patient was in a stable condition and subsequently discharged.

  Patient problems: Heart Block

  MAUDE report 50061262 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 29mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). During the procedure, the valve was able to be implanted successfully. Post-procedure on the following day, the patient had an ischemic stroke with hypotensive; also noted clinical signs of aphasia and left side drooping. No stroke was confirmed via Magnetic Resonance Imaging (MRI). The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The patient had an extended hospitalization and transferred to rehabilitation.

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

  MAUDE report 50024945 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 29mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). The patient has a prior medical history of Right Bundle Branch Block (RBBB) and Left Anterior Fascicular Block (LAFB) with QRS duration of 144ms. The length of the membranous septum was 4.4mm. 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 unspecified balloon and the patient went into a complete heart block. A temporary pacing wire was placed to stabilize the rhythm. During the procedure, the valve was able to be implanted successfully at a depth of 3mm on the non-coronary cusp (NCC). The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. On the following day, a permanent pacemaker was placed to resolve the event. The patient had an extended hospitalization. The patient was discharged.

  Patient problems: Heart Block

  MAUDE report 50024275 ↗

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-0494-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-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-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