Innova™ Vascular H74939293088030Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729874195), received between Feb 2, 2017 and Sep 23, 2025 — classified as 2 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2025Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND STRETCHED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). AN 8 X 80 X 130 INNOVA STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN DEPLOYMENT WAS ATTEMPTED, ONLY APPROXIMATELY 1.5CM OF THE STENT DEPLOYED. THE THUMB WHEEL WAS USED TO WHERE THEY COULD SEE THE INITIAL OPENING OF THE DISTAL END OF THE STENT; HOWEVER, THE WHEEL NO LONGER MOVED AT THAT POINT. THE PHYSICIAN ATTEMPTED TO PULL THE PLUNGER AT THE PROXIMAL END OF THE STENT DELIVERY SYSTEM (SDS), BUT IT WOULD NOT MOVE; IT WAS NOTED THAT THE PARTIALLY DEPLOYED STENT WAS OPPOSED TO THE VESSEL WALL. THE PHYSICIAN THEN PULLED BACK THE ENTIRE SDS IN AN ATTEMPT TO RETRIEVE THE STENT. THE STENT DEPLOYED AND BECAME STRETCHED IN THE SFA, COVERING THE LESION BUT ALSO STENTING MORE PROXIMALLY IN THE ARTERY. THE 80MM STENT WAS ESTIMATED TO BE APPROXIMATELY 120MM LONG IMPLANTED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23125993 ↗
• MalfunctionOct 4, 2021Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT STARTED TO DEPLOY BEFORE ENTERING THE BODY. A 8 X 80 X 130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR A BILATERAL EXTERNAL ILIAC STENTING PROCEDURE. THE SENT WAS INADVERTENTLY DEPLOYED PRIOR TO ENTERING THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12573458 ↗
• InjuryAug 26, 2021Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE EXTERNAL ILIAC WAS CALCIFIED. A 8X80MM INNOVA VASCULAR STENT WAS ADVANCED VIA A CONTRALATERAL APPROACH. THE STENT WAS DEPLOYED WITHOUT ISSUE, HOWEVER, WHEN REMOVING THE DELIVERY SYSTEM, THE NOSECONE BECAME STUCK ON THE STENT. THE STENT POPPED INTO THE AORTA. A 10X40MM MUSTANG BALLOON WAS DILATED ABOVE THE INNOVA STENT AND USED TO PULL THE STENT INTO THE RIGHT ILIAC ARTERY. THEN, TWO (2) 8X57MM EXPRESS LD STENTS WERE DEPLOYED IN THE LEFT AND RIGHT COMMON ILIAC ARTERY, TRAPPING THE INNOVA STENT IN THE LEFT ILIAC ARTERY. THE PATIENT TOLERATE THE PROCEDURE WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375156 ↗
• MalfunctionJun 3, 2020Entrapment of Device; Premature Activation; Detachment of Device or Device Component; Entrapment of Device; Premature Activation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED AND THE DELIVERY SYSTEM BECAME FROZE ON THE WIRE AND FRACTURED. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. POPLITEAL ACCESS WAS USED WITH A 6FR SUPER SHEATH. TWO STENTS AND BALLOONS WERE USED OVER THE AMPLATZ GUIDEWIRE. AN 8X80X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR USE. DURING PREPARATION FOR THE PROCEDURE, THE STENT AND DELIVERY SYSTEMS WERE APPROPRIATELY FLUSHED PRIOR TO LOADING AND LOCK WAS IN PLACE. UPON INSERTION OVER THE GUIDEWIRE AND DURING FORWARD ADVANCEMENT OUTSIDE THE PATIENT BODY, IT WAS NOTED THAT THE STENT HAD PARTIALLY DEPLOYED APPROXIMATELY 2CM. THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER BUT IT HAD BECOME STUCK TO THE GUIDEWIRE AND COULD NOT BE REMOVED WITHOUT USING SIGNIFICANT FORCE WHICH LED TO THE INNER SHAFT FRACTURING. THE FRAGMENTS WERE REMOVED FROM THE GUIDEWIRE WITH EXTREME FORCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER INNOVA STENT AND DIFFERENT GUIDEWIRE. NO PATIENT HARM OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10115260 ↗
• InjuryFeb 2, 2017Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ARM. A 8MM-80MM/130CM INNOVA¿ STENT WAS ADVANCED TO THE TARGET LESION. IT SEEMED TO BE DEPLOYING FINE, HOWEVER, AT THE END OF THE DEPLOYMENT RESISTANCE WAS MET AND A PIECE OF THE STENT BROKE OFF. A NON-BSC STENT WAS USED TO TACK IT DOWN SO IT WOULD NOT SLING INTO THE INFERIOR VENA CAVA. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6298081 ↗

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