Innova™ Vascular H74939293081230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729874218), received between Jun 19, 2019 and Dec 22, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Nonstandard Device; Incomplete or Missing Packaging; Nonstandard Device; Incomplete or Missing Packaging

  IT WAS REPORTED THAT PROFILE PROBLEM AND LABELING ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RIGHT ILIAC ARTERY. A 8 X 120 X 130 INNOVA VASCULAR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS DEPLOYED AND A 7X150 RANGER BALLOON WAS USED FOR POST-DILATION. IT WAS OBSERVED THAT THE STENT APPEARED TO BE LONGER THAN THE BALLOON, RESULTING IN A LONGER STENT THAN INTENDED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866819 ↗
• MalfunctionApr 24, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. THE PATIENT WAS BEING TREATED FOR ILIAC STENOSIS. AN 8 X 120 X 130 INNOVA VASCULAR WAS OPENED, FLUSHED, AND REMOVED FROM TRAY. THE STENT WAS BEING PLACED ON THE WIRE WHEN IT WAS NOTICED THAT THE END OF THE STENT WAS FLARED. THE CLIP WAS STILL ATTACHED TO THE DEPLOYMENT WHEEL AND HAD NOT BEEN MOVED. THE DEVICE WAS REMOVED FROM THE WIRE AND WAS DEPLOYED ON THE TABLE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177718 ↗
• InjuryJun 19, 2019Fracture; Fracture

  IT WAS REPORTED THAT A STENT FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS EXTERNAL ILIAC VEIN. FOLLOWING PRE-DILATION, AN 8 X 120 X 130 INNOVA SELF EXPANDING STENT WAS ADVANCED IPSILATERAL AND DEPLOYED WITHOUT INCIDENT. THE STENT WAS POST-DILATED WITH THREE BALLOONS. THE LAST BEING AN 8MM HIGH PRESSURE BALLOON. DURING THIS DILATION, THE BALLOON FRACTURED THE STENT. ANOTHER STENT WAS PLACED TO COVER THE FRACTURED INNOVA STENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE POST PROCEDURE. THERE WAS NO RESIDUAL AND THE STENT LOOKED GREAT WHEN THE PROCEDURE WAS COMPLETE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8713899 ↗

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