FlexNav™ FNAV-DS-SMRecalls & reported problems

Summary

The FDA's MAUDE database contains 212 adverse event reports that list this exact device (DI 05415067031372), received between Feb 10, 2022 and Sep 23, 2026 — classified as 8 deaths, 89 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (63 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 212 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Difficult to Insert

  Patient problems: Coronary obstruction/occlusion; Perforation

  MAUDE report 50875745 ↗
• InjurySep 23, 2026Difficult to Advance; Material Deformation; Material Twisted/Bent

  It was reported that on (b)(6) 2026, an unspecified Navitor valve was selected for implant using a small FlexNav Delivery System (DS). During the insertion of the DS while advancing a non-Abbott brand guidewire, the patient had experienced femoral artery dissection. Subsequently, while advancing the DS, team noticed a lack of progression and checked via fluoroscopy and the system was withdrawn from the patient's anatomy. Upon inspection, a kink was identified along with an unclear alteration at the tip of the DS. A new small FlexNav DS and guidewire were replaced, and the valve was able to be implanted successfully. Dissection was treated (unspecified) to resolve the event. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The patient was reportedly recovered from the procedure.

  Patient problems: Vascular Dissection

  MAUDE report 50863307 ↗
• MalfunctionSep 23, 2026Difficult to Advance; Material Deformation

  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's femoral was observed to be calcified and the right femoral vessel was selected as the access site. No issues were observed with the loading process. During the procedure, fluoroscopy showed that the DS was unable to be advance external iliac artery which was observed to be narrowed. The physician pushed/rotated the DS in an attempt to advance; however, the difficulty remained unchanged. Upon removal from the patient's anatomy, DS was observed to be damaged. A second 23mm, Navitor Vision valve was replaced using a new small FlexNav DS. A stiffer non-Abbott wire was replaced and the advancement was initiated. Once again, the DS was unable to advance at the external iliac. Multiple attempts were made to advance narrow anatomy, but the results remained unchanged. Upon removal from the patient's anatomy, DS was observed to be damaged. The physician selected left femoral as the access site. A third 23mm, Navitor Vision Valve was selected for implant using a small FlexNav DS and the system was able to be loaded without any issues. The valve wa

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863276 ↗
• MalfunctionSep 23, 2026Difficult to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863263 ↗
• InjurySep 21, 2026Difficult to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848468 ↗
• InjurySep 21, 2026Difficult to Remove

  It was reported that on (b)(6) 2026, an25mm, Navitor Vision valve was selected for implant using a small FlexNav Delivery System (DS). The patient has a torturous anatomy. During the procedure, the valve was able to be implanted. Upon removal, non-Abbott wire got stuck within the DS and it was unable to be removed. A 0.018 wire down the side of the integrated sheath of DS into the patient's body. The non-Abbot wire and DS were then removed together. Post-procedure, small localized pericardial effusion was observed in the right atrium and right ventricle with a largest dimension of 1.8 cm at the Right Ventricle (RV) and pericardial drainage was performed to resolve the event. The patient was in a recovering condition.

  Patient problems: Pericardial Effusion

  MAUDE report 50847616 ↗
• MalfunctionSep 21, 2026Difficult to Insert; Retraction Problem; Material Twisted/Bent; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847615 ↗
• 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 small FlexNav Delivery System (DS). Left femoral access was selected as the access site. During the procedure, the valve was able to be implanted. Post-implant, left femoral dissection was observed and a surgical intervention was performed to resolve the event. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The implanter believed that this was due to the walls of the vessel being weak and closure devices being ineffective due to the sensitive anatomy and not a failure of the devices. The patient was discharged.

  Patient problems: Vascular Dissection

  MAUDE report 50823045 ↗
• InjurySep 18, 2026Difficult to Advance

  (b)(4) VISTA Nova, Patient Site ID: (b)(6). It was reported that on (b)(6) 2026, a 23mm Navitor Valve with Radiopaque Markers was chosen for implant with a Small FlexNav Delivery System (DS). During procedure, the Small FlexNav DS could not pass through the right common iliac artery (CIA) due to severe calcification. A wire exchange was performed after 7mm plain old balloon angioplasty (POBA) with a non-Abbott balloon. The Small FlexNav DS was able to pass, however, the valve could not cross the sino-tubular junction due to severe calcification, as well. A snare was used to assist with delivery and successfully implant the valve. Patient remained hemodynamically stable throughout the procedure. Post-procedure after returning to the ward, patient complained of back pain. Computed tomography demonstrated an acute Type B aortic dissection extending from the distal aortic arch to the abdominal aorta. The physician attributed the cause of the aortic dissection related to difficulty of advancing the FlexNav DS through patient anatomy. Prolonged hospitalization was reported. Patient was administered medication.

  Patient problems: Pain; Vascular Dissection

  MAUDE report 50820166 ↗
• InjurySep 18, 2026Difficult to Remove; Retraction Problem; Difficult to Advance; Material Deformation

  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: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 50817858 ↗
• InjurySep 9, 2026Difficult to Advance

  It was reported that on (b)(6) 2026, a 25mm Navitor Vision valve was selected for implant using a small FlexNav Delivery System (DS). Computed Tomography (CT) revealed that the patient had significant vascular narrowing of the right vascular system and left common iliac vessel. Left femoral vessel was selected as the access site. 14 Fr, non-Abbott introducer sheath (IS) was inserted, and a non-Abbott wire was placed in the left ventricle. During the procedure, DS was inserted and following an inline sheath; upon advancement at the common iliac artery, the physician felt significant resistance at this site. It was attempted a couple of times; however, the advancement of the DS was unsuccessful. The procedure was aborted and rescheduled for an alternative access TAVI procedure at a later date. While closing the patient's femoral arteries, it was observed that the left femoral artery was perforated with bleeding and a stent was placed as an intervention to treat the condition. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The patient remained stable at the time of this report. On follow-up, the patient was

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 50682168 ↗
• InjuryAug 7, 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 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 valve was successfully implanted. Post-procedure, the patient developed oozing at the access-site. Manual pressure was held and epinephrine/lidocaine was given for treatment. The oozing was resolved without sequelae and the patient was discharged from the hospital the following day.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50180774 ↗
• MalfunctionAug 7, 2026Difficult to Insert; Material Deformation

  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 preparation, loading was completed, the valve check was performed without issue, and no overcapture was observed. Following exchange of a 4.7 mm (0.185 inch) non-Abbott sheath, the device was introduced via the transfemoral (TF) approach. The patient was reported to have tortuous anatomy; however, the tortuosity was not considered particularly severe. Resistance was encountered immediately upon insertion. The device was subsequently withdrawn, and it was observed that the tip of the valve capsule had folded back. The capsule tip was not split or torn. As a result, the 25 mm Navitor Vision Valve, Small FlexNav Delivery System, and Small Navitor Loading System were replaced. The loading system was replaced because it became non-sterile after loading had been completed. No allegation of malfunction was reported against the Small Navitor Loading System or the first 25 mm Navitor Vision Valve. The replacement device was successfully implanted. The patient did not experience any issues or adverse events during or after

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180634 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Information: CRD (b)(4) - Envision IDE Study, Patient Site C (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: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50135355 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI) were performed. At that time, a pericardial effusion was identified, and the transcatheter aortic valve implantation (TAVI) procedure was postponed. On 10 July 2026, a 25 mm Navitor Vision Valve was selected for implant using a Small FlexNav Delivery System (DS). The native valve annulus dimensions were reported as 21.3 mm (short axis) and 26.5 mm (long axis). No difficulty implanting the device, including multiple manipulations, was reported. The valve was not resheathed more than two times, and no multiple guidewire or delivery sheath exchanges were reported. Protamine was administered after the procedure. Following the procedure, the patient experienced hypotension, and echocardiography confirmed the presence of pericardial effusion within 48 hours post-procedure. The hypotension was treated with noradrenaline (norepinephrine), which elevated the patient's blood pressure. The implanter believed the hypotension was caused by an increase in pericardial fluid (pericardial effusion). No cardiac tamponade was reported. The cause of the pericardial effusion was unknown.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50133645 ↗
• InjuryJun 19, 2026Retraction Problem; Positioning Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 23MM, NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAS A PRIOR MEDICAL HISTORY OF PERIPHERAL VASCULAR DISEASE AND ARTERIOTOMIES IN THE ACCESS. RIGHT FEMORAL WAS SELECTED AS THE ACCESS SITE. CALCIFICATION WAS OBSERVED IN THE ACCESS SITE, UPON INSERTION OF THE FIRST PROGLIDE, SIGNIFICANT DIFFICULTY WAS FELT WHILE PUNCTURING. AFTER PLACEMENT OF THE FIRST PROGLIDE, THE FEMORAL ARTERY RUPTURED AND AN UNSPECIFIED PERIPHERAL BALLOON WAS USED TO CONTROL THE BLEEDING. AN ARTERIAL DISSECTION WAS REQUIRED TO ADVANCE THE DS. THE VALVE AND DS WERE PREPARED; DURING THE PROCEDURE, ON THE FIRST DEPLOYMENT ATTEMPT, IT APPEARED THAT THE NAVITOR VISION STENT HAD BROKEN; THE VALVE WAS RECAPTURED TWICE DUE TO POSITIONING ISSUE. AT THIS POINT, THE VALVE CAPSULE DID NOT FULLY RECAPTURED. ALL NECESSARY MANEUVERS WERE PERFORMED WITHOUT SUCCESS IN RECAPTURING THE VALVE, RESULTING IN DEPLOYING THE VALVE IN THE DESCENDING AORTA. A SECOND UNSPECIFIED VALVE WAS SELECTED FOR IMPLANT AND ADVANCED THROUGH THE DESCENDING AORTA. THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY WITHOUT COMPLICATIONS. THE PATIENT REMAINED HEMODYNAMICALLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566405 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2026 A NAVITOR VISION WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE DEVICE WAS IMPLANTED. POST-PROCEDURE A PERIPHERAL ANGIOGRAPHY OF THE RIGHT FEMORAL ARTERY REVEALED AN EXTRAVASATION OF THE VESSEL. A BALLOON ANGIOPLASTY WAS PERFORMED, WHICH RESOLVED THE EXTRAVASATION. THE USER BELIEVED THE EXTRAVASATION WAS CAUSED DURING THE EXCHANGE OF DEVICES WITH THE SHEATH USED FOR PRE-BALLOON AORTIC VALVULOPLASTY AND INSERTING THE DELIVERY SYSTEM. THE PATIENT STATUS WAS STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25113521 ↗
• MalfunctionMay 4, 2026Difficult to Insert; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). UPON INSERTION, APPROXIMATELY 6-8CM WAS INSERTED WITHOUT ISSUE; SUBSEQUENTLY LOSS OF NON-ABBOTT WIRE POSITION WAS OBSERVED. VALVE AND DS WERE REMOVED FROM THE PATIENT'S ANATOMY, CLEANED AND INSPECTED. NO DEFORMATION OF THE VALVE CAPSULE WAS NOTED, UPON REINSERTION, DS CAUGHT AT THE SKIN LEVEL THEN UNABLE TO BE ADVANCED, DEFORMATION WAS NOTED AT THE EDGE OF VALVE CAPSULE, SO A NEW VALVE WAS PREPARED FOR IMPLANT USING A NEW FLEXNAV DS. SURGEON OBSERVED A SKIN TAG DURING INSERTION OF THE NEW DS, SKIN INCISION WAS EXTENDED AND DS WAS INSERTED THROUGH ARTERIOTOMY WITHOUT AN ISSUE. THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PATIENT WAS IN A STABLE CONDITION AND SUBSEQUENTLY DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074420 ↗
• InjuryApr 10, 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 DID NOT HAVE A TORTUOUS ANATOMY. DURING THE PREPARATION, VALVE WAS PREPARED AND LOADED AS PER THE IFU INSTRUCTIONS. PATIENT'S FEMORAL ILIAC ARTERY WAS MEASURED TO BE 5MM WITH CALCIFICATION. DURING THE PROCEDURE, THERE WAS NO DIFFICULTY IN ADVANCEMENT OR INSERTION OF THE DS IN THE PATIENT'S ANATOMY, AND THE VALVE WAS ABLE TO BE IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. POST-IMPLANT, BLEEDING WAS NOTED IN THE PUNCTURE SITE, AND A STENT WAS PLACED TO RESOLVE THIS EVENT. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24841010 ↗
• DeathApr 10, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  It was reported that on (b)(6) 2026, a 25mm Navitor Vision valve was selected for implant using a small FlexNav Delivery System (DS). Prior to the procedure, the patient was considered a high¿risk patient with severe vascular disease. The patient has a prior medical history of Atrial fibrillation (Afib) and Renal insufficiency. Both femoral accesses were observed to be small and calcified. 12Fr, non-Abbott introducer sheath (IS) was inserted through the left carotid vessel. Pre-implant Balloon Valvuloplasty (Pre-BAV) was performed using a 20mm, non-Abbott balloon. During the procedure, temporary pacemaker placed, the DS was observed to be on the inner curvature due to the access site. In order to centralize, the DS and non-Abbott wire were pushed at the same time. Several partial and full recaptures (more than two times) were also performed to centralize the DS, and the valve was able to be implanted. It was reported that manual resheath was performed to retrieve the system. At this moment, the patient's pressure dropped; circumferential pericardial effusion was noted in the apex; progressed to cardiac tamponade due to ventricular laceration. Pericardial drainage was performed and

  Patient problems: Brain Injury; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion

  MAUDE report 24840975 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6) - VISTA NOVA 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 VALVE WAS SUCCESSFULLY IMPLANTED. IT WAS BELIEVED THAT INSERTING THE FLEXNAV DELIVERY SYSTEM INTO THE SMALL VESSEL CAUSED A VASCULAR DISSECTION, WHICH SUBSEQUENTLY LED TO AN OCCLUSION. FOR TREATMENT, A PERCUTANEOUS OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 24769531 ↗
• DeathMar 30, 2026Difficult to Advance

  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). PRIOR TO THE PROCEDURE, THE PATIENT WAS IN A STABLE CONDITION. THE PATIENT HAD SEVERE CALCIFIED ANATOMY IN THE ASCENDING AND ABDOMINAL AORTA. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 17 MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, THE DS WAS UNABLE TO ADVANCE THE SINOTUBULAR JUNCTION (STJ) CALCIUM DEPOSITS, SO IT WAS RETRACTED DOWN TO THE ABDOMINAL AORTA. DURING THE TIME OF DISCUSSION ON CONTINUING WITH THE NEXT STEPS, THE PATIENT BECAME HYPOTENSIVE AND A CARDIOPULMONARY RESUSCITATION (CODED) WAS PERFORMED, AND MEDICATION (UNSPECIFIED) WAS ADMINISTERED, SUBSEQUENTLY THE PATIENT WAS PRONOUNCED TO BE DECEASED. THE PHYSICIAN STATED THAT HE DOES NOT BELIEVE IT WAS A PRODUCT ISSUE OTHER THAN NOT BEING ABLE TO CROSS CALCIFIED STJ. ADDITIONALLY, HE STATED THAT THE ADVERSE CONSEQUENCES WERE DUE TO PATIENT'S ANATOMY, FRAILTY, AND BEING HIGH RISK FOR THE PROCEDURE. THE OFFICIAL CAUSE OF DEATH WAS CIRCULATORY COLLAPSE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24720635 ↗
• MalfunctionMar 30, 2026Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6). 2026, A 23MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). SEVERE CALCIFICATION IN THE COMMON ILIAC ARTERY (CIA) AND EXTERNAL ILIAC ARTERY (EIA) WAS OBSERVED. CIA WAS DILATED USING A 7.0/40, NON-ABBOTT BALLOON AND EIA BY 6.0/40, NON-ABBOTT BALLON USING A PLAIN OLD BALLOON ANGIOPLASTY (POBA) PROCEDURE. A 14 FR, NON-ABBOTT INTRODUCER SHEATH (IS) WAS ADVANCED WITH DIFFICULTY. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 18MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, THE DS WAS UNABLE TO ADVANCED DUE TO THE EIA CALCIFICATION. UPON WITHDRAWING THE DS, THE TIP OF THE VALVE CAPSULE WAS OBSERVED TO BE FRAYED, AND IT WAS REPLACED WITH A NEW SMALL FLEXNAV DS. WIRE WAS ALSO NOTED TO BE REPLACED WITH ANOTHER NON-ABBOTT WIRE, THEN THE PASSAGE WAS SUCCESSFUL. THE VALVE WAS ABLE TO BE IMPLANTED. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PATIENT WAS IN A STABLE CONDITION AND SUBSEQUENTLY DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719329 ↗
• MalfunctionMar 20, 2026Retraction Problem; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAS A PRIOR MEDICAL HISTORY NOTABLE FOR A BIVENTRICULAR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (BIV ICD); THEREFORE, BASELINE WAS PACED AND SEVERE AORTIC STENOSIS. MEMBRANOUS SEPTUM MEASUREMENT WAS UNCLEAR. FLUOROSCOPY CHECK WAS CONFIRMED AND A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 20MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, DURING THE SECOND RECAPTURE, THE RADIOPAQUE TIP WAS NOT FULLY RETRACTED INTO THE VALVE CAPSULE. UPON REMOVAL, THE DS WAS DEFORMED AND A NEW 25MM NAVITOR VISION VALVE WAS LOADED FOR IMPLANT USING A NEW SMALL FLEXNAV DS. FLUOROSCOPY WAS PERFORMED PRIOR TO INSERTION. THE VALVE WAS ABLE TO BE IMPLANTED IN CUSP OVERLAP VIEW AT A DEPTH OF 4MM ON THE NON-CORONARY CUSP (NCC) AND 6MM ON THE LEFT-CORONARY CUSP (LCC). NO PARAVALVULAR LEAK (PVL) WAS NOTED. FINAL GRADIENT WAS 1MMHG. THE PATIENT'S CARDIAC RHYTHM REMAINED UNCHANGED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648893 ↗
• MalfunctionFeb 20, 2026Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 20MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED. IT WAS CONFIRMED THAT ALL THE RETAINER TABS WERE RELEASED. UPON WITHDRAWAL OF THE DS, THE TIP CAUGHT ON THE VALVE LEADING IT TO BE PULLED UP INTO THE ASCENDING AORTA. THE VALVE WAS SURGICALLY REMOVED, AND A NEW SURGICAL VALVE WAS IMPLANTED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405930 ↗

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