Innova™ Vascular H74939293086070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729873822), received between Aug 28, 2020 and Mar 18, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• InjuryMar 18, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED, REQUIRING PLACEMENT OF ANOTHER STENT. THE OVER 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC ARTERY. AN 8.0X30X75CM EXPRESS LD STENT WAS USED FOR TREATMENT. HOWEVER, AFTER DEPLOYMENT, AN ANGIOGRAM SHOWED THAT THE DISTAL END OF THE STENT WAS UNRAVELED AND APPEARED TO FELL APART. AS A RESULT, AN EXPRESS LD 8X20X135 WAS DEPLOYED TO COVER THE PORTION OF THE PREVIOUS STENT. THE CATHETER WAS REMOVED WITH NO ISSUES, AND THE PROCEDURE WAS COMPLETED. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632499 ↗
• MalfunctionAug 28, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS BENT. A 8 X 60 X 75 INNOVA VASCULAR STENT WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE STENT WAS BENT AND WAS UNABLE TO BE USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10464877 ↗

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