FlexNav™ FNAV-LS-LGRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067031440), received between Mar 31, 2023 and Mar 31, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM PORTICO VALVES WAS SELECTED FOR AN IMPLANT. THE ANNULAR DIMENSION OF THE NATIVE VALVE WAS AORTIC ANNULUS PERIMETER: 80.6 MM. THE IMPLANT DEPTH AT DEPLOYMENT WAS NOTED AS 2MM. THE IMPLANTED DEPTH AT RELEASE WAS 1MM. THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. DURING FINAL RELEASED OF THE VALVE, THE VALVE MIGRATED DUE TO FORWARD TENSION APPLIED ON THE FLEXNAV DELIVERY SYSTEM DURING FINAL DEPLOYMENT. THE VALVE WAS NOT SNARED. THE PATIENT DID NOT HAVE A HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. THE MIGRATED VALVE DID NOT BLOCK A CORONARY ARTERY. THERE WAS NO INTERACTION BETWEEN THE DELIVERY SYSTEM AND THE VALVE. THERE WAS NO DIFFICULTY WITH DEPLOYING OR RETRACTING THE VALVE DURING THE PROCEDURE. THE PATIENT'S GRADIENT WAS NOTED AS 15 MMHG FOLLOWING THE IMPLANT. A 2ND 29MM PORTICO VALVE WAS SELECTED IN A VALVE-IN-VALVE PROCEDURE. THE PATIENT'S STATUS WAS NOTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657598 ↗

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-0492-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
• Z-0491-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
• Z-0495-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
• Z-0493-2025 · Oct 17, 2024 · Open, Classified
  Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
• Z-0494-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile