Innova™ Vascular H74939293081530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729874225), received between Mar 14, 2021 and Sep 1, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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.

• InjurySep 1, 2022Activation, Positioning or Separation Problem; Device-Device Incompatibility; Activation, Positioning or Separation Problem; Device-Device Incompatibility

  MEDWATCH (B)(4). IT WAS REPORTED THAT PARTIAL DEPLOYMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 8 X 150 X 130 INNOVA VASCULAR WAS SELECTED FOR USE. THE STENT WAS PLACED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND DEPLOYED; HOWEVER, THE STENT DID NOT FULLY EXPAND TOWARDS THE LAST PART. THE ENTIRE SYSTEM WAS PULLED TO DELIVER THE REMAINING 30 MM OF THE STENT ONCE THE STENT STOPPED DEPLOYING USING THE THUMB WHEEL. THE STENT ELONGATED. A NON-BOSTON SCIENTIFIC BALLOON WAS USED TO OPEN THE REST OF THE STENT. THE BALLOON GOT STUCK INSIDE THE STENT RESULTING IN PROLONGED FLUOROSCOPY TIME TO REMOVE THE BALLOON. AFTER SEVERAL ATTEMPTS, THE BALLOON WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334053 ↗
• InjuryMar 14, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE STENT WAS FOUND TO BE SHORTER THAN WHAT WAS LABELED ON THE PACKAGING, AND ADDITIONAL INTERVENTION WAS REQUIRED. AN 8MM X 150MM X 130CM INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE IN A STENTING PROCEDURE. DURING THE PROCEDURE, THE STENT WAS IMPLANTED, BUT IT WAS FOUND TO BE SHORTER THAN WHAT WAS LABELED ON THE PACKAGING. THE IMPLANTED STENT LENGTH WAS MEASURED TO BE 110MM, WHICH WAS 40MM SHORTER THAN EXPECTED. AN ADDITIONAL 8MM X 60MM X 130MM STENT WAS IMPLANTED WITH 10MM OF OVERLAP IN ORDER TO COVER THE MISSED SEGMENT. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478975 ↗

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