Innova™ Vascular H74939293084070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729873815), received between Jul 7, 2017 and Oct 4, 2021 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. AN 8 X 40 X 75 INNOVA VASCULAR SELF EXPANDING STENT WAS SELECTED FOR AN ARTERIAL STENT PLACEMENT PROCEDURE FOR EXTERNAL ILIAC STENOSIS. WHEN THE PACKAGE WAS OPENED DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS PARTIALLY DEPLOYED IN THE PACKAGING. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569629 ↗
• MalfunctionMar 29, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT WAS INADVERTENTLY DEPLOYED. A 8MM X 40MM X 75CM INNOVA SELF-EXPANDING STENT WAS CHOSEN FOR AN ILIAC STENT PROCEDURE. THE STENT WAS OPENED IN THE STERILE FIELD. WHEN FLUSHING THE STENT, THE PHYSICIAN NOTICED THAT THE STENT WAS PARTIALLY DEPLOYED. THE SAFETY LOCK WAS ON THE DEVICE AND THE DEVICE NEVER ENTERED THE PATIENT. A SECOND DEVICE WAS OPENED. THE SECOND DEVICE WAS FLUSHED AND DEPLOYED WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11584581 ↗
• InjurySep 23, 2020Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT THE STENT FAILED TO EXPAND, REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED FOR A RIGHT LOWER EXTREMITY ARTERIOGRAM. AN 8X40X75 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE IN THE POPLITEAL ARTERY. POSTERIOR TIBIAL ACCESS WAS OBTAINED FOR RETROGRADE TREATMENT. DURING DEPLOYMENT, THE STENT WAS HUNG UP ON THE DEPLOYMENT DEVICE. THE PHYSICIAN SUCCESSFULLY ATTEMPTED TO PUSH THE STENT OFF WITH A BALLOON. HOWEVER, THE STENT DID NOT EXPAND, EVEN WHEN DETACHED FROM THE DEPLOYMENT SHAFT. THE DEPLOYMENT DEVICE WAS REMOVED AND DAMAGE TO THE POSTERIOR TIBIAL ARTERY WAS NOTED. ANTERIOR TIBIAL AND PERONEAL ARTERIES REMAINED INTACT. A SNARE WAS USED TO ATTEMPT TO REMOVE THE STENT. BUT DUE TO THE ASSOCIATED RISKS, THE PHYSICIAN THEN DECIDED TO AFFIX AND OPPOSE THE STENT AGAINST THE VESSEL WALL WITH A NEW INNOVA STENT. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available; Perforation of Vessels

  MAUDE report 10574941 ↗
• MalfunctionJul 7, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 8 X 40 X 75 INNOVA STENT WAS SELECTED FOR A PROCEDURE IN THE EXTERNAL ILIAC. WHEN THE STENT WAS LOADED ONTO THE WIRE, IT STARTED TO DEPLOY. THIS OCCURRED DURING INTRODUCTION OUTSIDE THE PATIENT'S BODY. THE STENT WAS REMOVED FROM THE WIRE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6693492 ↗

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