Navitor™ NVTR-LS-SMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067036667), received between Dec 5, 2025 and Dec 5, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 18, 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.

• InjuryDec 5, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT ON (B)(6) 2025, A FLEXNAV DELIVERY SYSTEM (DS) WAS PREPARED FOR TREATMENT. THE PATIENT PRESENTED WITH MITRAL REGURGITATION (MR) AND HYPOTENSION, REQUIRING ADMINISTRATION OF VASOPRESSORS AND INTRAVENOUS FLUIDS. IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE STABILIZED. LOADING WAS INITIATED FOLLOWING THE STANDARD PROCEDURE. THE LOADING TUBE WAS INSERTED FROM THE TIP OF THE VALVE CAPSULE, AND INSTRUCTIONS WERE GIVEN TO STOP AT THE POINT OF RESISTANCE. HOWEVER, AFTER SEVERAL UP AND DOWN MOVEMENT, THE RESISTANCE COMPLETELY DISAPPEARED. IT WAS NOTED THAT WHILE THE VALVE'S STRUTS WERE ATTEMPTED TO PASS OVER THE CONE OF THE DELIVERY SYSTEM, THE LOADING FUNNEL AND LOADING BASE WAS COMPRESSED SLIGHTLY TO ALLOW THE AORTIC END OF THE VALVE TO OPEN. THERE WERE NO CROSSED OR MISALIGNED STRUTS, AND THERE WAS NO EXCESS FORCE REQUIRED TO TURN THE RE-SHEATH WHEEL WHILE ATTEMPTING TO RETRACT THE VALVE INTO THE DELIVERY SYSTEM. THE LOADING TUBE HAD BEEN POSITIONED PER THE INSTRUCTIONS FOR USE (IFU) AND THE CORRECT BASE INSERT WAS USED. THE FLEXNAV WAS REMOVED AND REPLACED. A NEW FLEXNAV DS WAS USED, AND LOADING WAS COMPLETED WITHOUT ANY ISSUES. A 23MM NAVITOR WAS IMPLANTED, AND T

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725453 ↗

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