FlexNavRecalls & reported problems across all models

We found 3 models of FlexNav by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 560 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2021 and Sep 23, 2026 — classified as 23 deaths, 205 injuries, 332 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (173 reports).

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

Most reported FlexNav problems

FlexNav models

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

• FlexNav™ FNAV-DS-LG

  Aortic valve, prosthesis, percutaneously delivered
  15 deaths347 reports
• FlexNav™ FNAV-DS-SM

  Aortic valve, prosthesis, percutaneously delivered
  8 deaths212 reports
• FlexNav™ FNAV-LS-LG

  Aortic valve, prosthesis, percutaneously delivered
  1 report

Recent FlexNav adverse event reports

The 15 most recent reports across all models, 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Subsequently, while advancing the DS, team noticed a lack of progression and checked via fluoroscopy and the system was withdrawn from the patient's anatomy.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; Retraction Problem; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847783 ↗
• 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 ↗
• MalfunctionSep 18, 2026Retraction Problem

  It was reported that on (b)(6) 2026, a 35mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). The patient's aortic valve was measured to be 53 degrees. During the procedure, two recaptures were performed since it was unable to achieve appropriate depth. The valve was not able to be recaptured completely, and the DS was retracted into the abdominal aorta then micro-adjustment wheel was attempted to close the gap, but the valve was still unable to be recaptured completely. A new 35mm, Navitor Vision valve was replaced using a new large FlexNav DS and able to be implanted successfully. 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 50819444 ↗
• MalfunctionSep 18, 2026Off-Label Use; Retraction Problem

  It was reported that on (b)(6)2026, a 35mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). The patient has a prior medical history of being implanted with a Bi-Ventricular pacemaker and 27mm non-Abbott surgical valve. During the procedure, on the initial attempt, the valve was in deeper position, and it was attempted for a partial recapture then the valve capsule migrated above the annulus requiring a full recapture of the valve. DS was retracted back into the descending aorta, and multiple rotations were made with the micro-adjustment wheel. However, it was unable to fully recapture the valve, and the DS was removed from the patient's anatomy. A new 35mm, Navitor Vision valve was replaced by using a new large FlexNav DS resulting in successful implantation. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818507 ↗
• 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 ↗
• MalfunctionAug 27, 2026Retraction 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). During the procedure, after two recapture attempts, the valve was unable to be recaptured completely. DS was pulled into the descending aorta, then micro-adjustment wheel was used, and the valve was able to be recaptured but the gap remained. A new 29mm Navitor Vision valve was replaced using a new large FlexNav DS resulting in successful implantation. 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 50479039 ↗

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