Innova™ Vascular H74939293056030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729873914), received between Jul 13, 2026 and Jul 20, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (P140028); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Fracture

  IT WAS REPORTED THAT THE STENT FRACTURED OCCURRED.A 5 X 60 X 130 INNOVA STENT SELF EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS DEPLOYED, HOWEVER, THE DEVICE FRACTURED DURING DEPLOYMENT AND WAS RETRACTED AND REMOVED FROM THE PATIENT. A REPLACEMENT INNOVA STENT WAS THEN USED, BUT THE SAME ISSUE OCCURRED. A THIRD INNOVA STENT WAS SUBSEQUENTLY OPENED AND DEPLOYED SUCCESSFULLY, ALLOWING THE PROCEDURE TO BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883625 ↗
• MalfunctionJul 13, 2026Fracture

  IT WAS REPORTED THAT THE STENT FRACTURED OCCURRED. A 5 X 60 X 130 INNOVA STENT SELF EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS DEPLOYED, HOWEVER, THE DEVICE FRACTURED DURING DEPLOYMENT AND WAS RETRACTED AND REMOVED FROM THE PATIENT. A REPLACEMENT INNOVA STENT WAS THEN USED, BUT THE SAME ISSUE OCCURRED. A THIRD INNOVA STENT WAS SUBSEQUENTLY OPENED AND DEPLOYED SUCCESSFULLY, ALLOWING THE PROCEDURE TO BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25796562 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140028. One submission often covers many models, so check the product and lot details in each record.

• Z-0685-2018 · Nov 6, 2017 · Open, Classified
  Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated t
• Z-0686-2018 · Nov 6, 2017 · Open, Classified
  Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated