Innova™ Vascular H74939293084030Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729874171), received between Sep 26, 2018 and Jul 3, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY. AN 8 X 40 X 130 INNOVA STENT WAS SELECTED FOR TREATMENT VIA CONTRALATERAL APPROACH. HOWEVER, AFTER THE STENT WAS PREPPED AND ADVANCED OVER THE GUIDEWIRE, THE STENT BEGAN TO FLOWER AT THE HUB OR DIAPHRAGM OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH AN 8X60 INNOVA STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670552 ↗
• MalfunctionAug 9, 2023Difficult or Delayed Positioning; Difficult to Remove; Device-Device Incompatibility; Material Deformation; Difficult or Delayed Positioning; Difficult to Remove; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE STENT STRUT WAS DAMAGED.AN INNOVA VASCULAR 8 X 40 X 130 WAS SELECTED FOR USE IN A PLANNED INTERVENTION TO TREAT THE PATIENT'S PERIPHERAL ARTERY DISEASE. THE TARGET LESION WAS REPORTED TO BE 75% STENOSED WITH SEVERE CALCIFICATION AND MILD TORTUOSITY. BILATERAL GROIN ACCESS WAS ATTAINED WITH 6FR SHEATHS. THE PHYSICIAN COMPLETED INTRAVASCULAR LITHOTRIPSY (IVL) OF THE RIGHT COMMON AND EXTERNAL ILIAC, FIRST WITH A 6 MM NON-BOSTON SCIENTIFIC IVL DEVICE OR A NON-BOSTON SCIENTIFIC 0.014 300 CM WIRE. IT WAS DETERMINED THAT NO STENT WAS NEEDED ON THE RIGHT SIDE. THE PHYSICIAN MOVED TO THE LEFT GROIN SHEATH WITH THE NON-BOSTON SCIENTIFIC IVL DEVICE AND TREATED THE COMMON AND EXTERNAL ILIAC OVER THE 0.014 WIRE. POST IVL, THERE WAS A SMALL DISSECTION OF THE LEFT EXTERNAL ILIAC. THE PHYSICIAN DECIDED ON AN INNOVA VASCULAR 8 X 40 X 130 FOR THE AREA. THE STENT WAS PREPPED PROPERLY AND INSERTED OVER THE 0.014 WIRE AND WAS DEPLOYED FULLY IN THE CORRECT POSITION OF THE DISSECTION. WHEN THE PHYSICIAN WENT TO PULL THE DELIVERY SYSTEM OUT OF THE PATIENT, THE DELIVERY SYSTEM BEGAN TO CATCH ON THE STENT STRUT AND MALFORMED THE STENT SLIGHTLY. THE PHYSICIAN STOPPED IMMEDIAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494659 ↗
• MalfunctionNov 18, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT DEPLOYED PREMATURELY. AN INNOVA 8 X 40 X 130 WAS SELECTED FOR USE IN THE RIGHT COMMON ILIAC ARTERY TO TREAT ILIAC STENOSIS. THE TARGET LESION WAS ACCESSED VIA THE RIGHT FEMORAL ARTERY. AS THE DELIVERY SYSTEM WAS ADVANCED THROUGH THE TARGET LESION, IT PASSED THROUGH A RECENTLY DEPLOYED STENT, AT WHICH POINT THE INNOVA STENT WAS INADVERTENTLY DEPLOYED. BOTH THE STENT AND DELIVERY SYSTEM WERE REMOVED WITHOUT ISSUE. THE DEVICE WAS REPLACED WITH AN ELUVIA 8 X 40 X 120 IN ORDER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828318 ↗
• MalfunctionSep 20, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. AN 8 X 40 X 130 INNOVA VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN THE PERIPHERAL INTERVENTION PROCEDURE. DURING PREPARATION, HOWEVER, THE STENT PARTIALLY DEPLOYED BEFORE BEING INTRODUCED INTO THE PATIENT. THE STENT WAS NOT USED, AND ANOTHER MODEL WAS OPENED FOR USE WITHOUT INCIDENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459301 ↗
• MalfunctionJul 2, 2019Difficult to Insert; Premature Activation; Activation, Positioning or Separation Problem; Difficult to Insert; Premature Activation; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PREMATURE STENT DEPLOYMENT OCCURRED. A 8X40X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR AN AORTIC RUNOFF PROCEDURE IN THE ILIAC AND SUPERFICIAL FEMORAL ARTERY (SFA). THE STENT SYSTEM WAS BEING LOADED INTO THE INTRODUCER SHEATH WHEN RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN THEN WITHDREW THE SYSTEM AND THE STENT STARTED TO DEPLOY INSIDE THE SHEATH. THE ENTIRE SYSTEM WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755196 ↗
• MalfunctionFeb 19, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. A 8X40X130 INNOVA STENT WAS SELECTED FOR USE FOR A PROCEDURE. WHILE TRYING TO ADVANCE THE INNOVA THROUGH TORTUOUS ANATOMY, THE STENT BEGAN TO PREMATURELY DEPLOY. THE CATHETER AND STENT WERE REMOVED FROM THE PATIENT, AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8350827 ↗
• MalfunctionSep 26, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY PARTIALLY DEPLOYED. AN 8 X 40 X 130 INNOVA WAS SELECTED FOR A PROCEDURE IN THE RIGHT EXTERNAL ILIAC. THE DEVICE WAS PULLED OUT OF THE HOOP FOR PREPARATION AND IT APPEARED TO HAVE ALREADY BEEN PARTIALLY DEPLOYED. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. AN 8X40X75 STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7911338 ↗

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