Innova™ Vascular H74939293078070Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729873747), received between Feb 13, 2019 and Feb 13, 2019 — classified as 1 death.

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

• DeathFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED DURING PROCEDURE. THE PATIENT PRESENTED WITH OCCLUSION OF THE AORTA AND BILATERAL ILIAC ARTERIES. THE TARGET LESION WAS 100% STENOSED. MULTIPLE BALLOONS WERE USED TO DILATE AN OPEN CHANNEL IN THE OCCLUSION, INCLUDING A CHARGER BALLOON. THERE WERE NO REPORTED ISSUES WITH THE USE OF THE CHARGER BALLOON. AFTER DILATION, THE RENAL ARTERY WAS FIRST STENTED WITH A NON-BSC STENT. THE AORTA WAS THEN STENTED WITH A NON-BSC STENT. THE OSTIAL COMMON ILIAC WAS STENTED WITH NON-BSC COVERED STENTS. THESE STENTS WERE EXTENDED IN THE ILIAC REGION USING THREE 8X100X75MM INNOVA STENTS, AND ONE 7X80X75MM INNOVA STENT. THERE WERE NO REPORTED ISSUES OBSERVED DURING THE DEPLOYMENT OF THE INNOVA STENTS. HOWEVER, THE PATIENT ULTIMATELY DIED DURING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE PATIENT DIED DUE TO A PERFORATION IN THE RIGHT COMMON ILIAC. THE PATIENT DIED DURING PROCEDURE. THE CATH LAB MANAGER REPORTED THAT NO BSC PRODUCTS WERE ATTRIBUTED TO THE CAUSE OF DEATH.

  Patient problems: Death

  MAUDE report 8336357 ↗

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-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
• 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