Innova™ Vascular H74939293080230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729874164), received between Sep 29, 2017 and Mar 26, 2019 — classified as 3 malfunctions.

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

• MalfunctionMar 26, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. A 8X20X130 INNOVA STENT WAS SELECTED FOR A PROCEDURE. DURING PREPARATION, THE STENT DEPLOYED FROM THE DELIVERY SYSTEM OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN 8X40 INNOVA STENT SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8454104 ↗
• MalfunctionMar 8, 2019Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER BROKE. A 8X20X130 INNOVA VASCULAR STENT WAS SELECTED FOR USE DURING A PATIENT ILIAC STENT PROCEDURE. A NON-BSC .035 WIRE WAS SELECTED AND THE INNOVA STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED ON THE WIRE. HOWEVER, DURING ADVANCEMENT WHILE OUTSIDE THE PATIENT, THE CATHETER BECAME STUCK ON THE WIRE AND COULD NOT BE REMOVED. WHILE TRYING TO PULL THE SDS OFF OF THE WIRE, IT WAS THOUGHT THAT THE CATHETER BECAME BROKEN. IN HOPES TO MAINTAIN WIRE POSITION WITHIN THE PATIENT, THE PHYSICIAN DEPLOYED THE STENT OUTSIDE THE BODY. THE PHYSICIAN HOPED THAT THE RELEASE OF THE STENT WOULD LOOSEN UP THE SDS AND ALLOW IT TO BE REMOVED FROM THE WIRE, BUT THE DEVICE REMAINED STUCK. ULTIMATELY EVERYTHING WAS REMOVED FROM THE PATIENT AND ANOTHER WIRE AND A LONGER STENT WERE USED TO COMPLETE THE PROCEDURE. THE INNOVA SDS AND STENT WAS NEVER INTRODUCED INTO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATED BY MANUFACTURER: THE RETURNED PRODUCT CONSISTED OF AN INNOVA SELF-EXPANDING STENT SYSTEM WITH A 0.03 INCH GUIDEWIRE INSIDE THE DEVICE. THE OUTER SHEATH, TIP, INNER SHEATH AND THE REMAINDER OF THE DEVICE WERE CHECKED FOR DAMAGE. VISUAL EXAMINATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8404807 ↗
• MalfunctionSep 29, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE 8X20X130 INNOVA¿ STENT PREMATURELY DEPLOYED PRIOR TO PATIENT INTRODUCTION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6904134 ↗

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