Innova™ Vascular H74939293071230Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729874126), received between May 25, 2017 and Nov 6, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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.

• InjuryNov 6, 2025Deformation Due to Compressive Stress; Material Deformation; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT FEMORAL ARTERY ACCESS TO RIGHT SUPERFICIAL FEMORAL ARTERY VIA ANTEGRADE APPROACH. THE VESSEL LENGTH WAS APPROXIMATELY 120MM. A 6.0 X 150 X 150 RANGER BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION IN THE ANGIOPLASTY PROCEDURE. POST ANGIOPLASTY, IT WAS NOTED THAT THE LESION HAD SOME RECOIL. THUS, A 7 X 120 X 130 INNOVA VASCULAR WAS SELECTED FOR USE. UPON DEPLOYMENT, THE STENT DID NOT LOOK TO BE 120MM IN LENGTH. THE STENT WAS DEPLOYED. THE PHYSICIAN DECIDED NOT TO DEPLOY A SECOND STENT TO COVER ANY PORTION OF THE LESION THAT WAS MISSED, SINCE THE SAME RANGER WAS USED TO POST DILATE BOTH ENDS AND THE AREA EXTENDING BEYOND THE STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487608 ↗
• MalfunctionFeb 3, 2023Premature Activation; Difficult to Remove; Difficult to Advance; Premature Activation; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN ADVANCING THE STENT THROUGH THE SHEATH, AND THE STENT BEGAN TO DEPLOY PREMATURELY. ADDITIONALLY, THERE WAS RESISTANCE UPON REMOVAL. AN INNOVA 7 X 120 X 130 WAS SELECTED FOR USE. DURING INSERTION OF THE DELIVERY SYSTEM INTO THE 6F SHEATH, THERE WAS RESISTANCE NOTED. WHEN THE DELIVERY SYSTEM WAS APPROXIMATELY HALF-WAY INTO THE SHEATH, THE STENT BEGAN TO DEPLOY PARTIALLY. THE DELIVERY SYSTEM AND STENT WERE REMOVED WITH SIGNIFICANT RESISTANCE NOTED. THE INNOVA WAS REPLACED WITH AN EPIC VASCULAR SELF-EXPANDING STENT, WHICH WAS ABLE TO ADVANCE THROUGH THE SAME 6F SHEATH WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294329 ↗
• MalfunctionAug 26, 2022Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 7 X 120 X 130 INNOVA VASCULAR SELF-EXPANDING STENT WAS SELECTED FOR USE IN A PERIPHERAL STENTING PROCEDURE TO TREAT CLAUDICATION. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND NON-TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA). UPON TRYING TO CROSS THE BLOCKAGE IN THE LEFT SFA AND BEING UNSUCCESSFUL, THE STENT WAS REMOVED INTACT. HOWEVER; IT WAS NOTICED THAT THE STENT HAD MIGRATED FORWARD ON THE DELIVERY SYSTEM APPROXIMATELY 1/2CM. THEREFORE; THE DEVICE WAS NOT USED AND A SECOND DEVICE OF THE SAME SIZE WAS IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302929 ↗
• MalfunctionJan 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STENT FORESHORTENED. A 7MM X 120MM X 130CM INNOVA WAS SELECTED FOR USE IN A RIGHT LEG ANGIOGRAM WITH INTERVENTION AND POPLITEAL ACCESS. THE 70-80% STENOSED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS NOT CALCIFIED, AND THE ANATOMY WAS NOT TORTUOUS. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE STENT WAS APPROXIMATELY 20% DEPLOYED IN THE DISTAL SFA WHEN THE STENT WAS NOTED TO HAVE FORESHORTENED. THE STENT WAS FULLY DEPLOYED WITHOUT RESISTANCE AND POST-DILATED. THE INNOVA FORESHORTENED FROM ITS STATED 120MM LENGTH TO APPROXIMATELY 100MM IN LENGTH. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11165081 ↗
• InjurySep 8, 2020Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT A PARTIAL DEPLOY OCCURRED AND THE STENT FORESHORTENED. A 7X120X30 SELF-EXPANDING INNOVA STENT WAS SELECTED FOR USE IN A PROCEDURE IN A STENOSED SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT DID NOT DEPLOY PROPERLY AS THE STENT FORESHORTENED AND ONLY DEPLOYED 80MM OF THE 120MM. THERE WERE NO PATIENT COMPLICATIONS REPORTED. A NON-BSC STENT WAS USED TO COMPLETE THE REMAINING LENGTH OF STENT NEEDED. IT WAS FURTHER REPORTED THAT THE CASE WAS AN ANTEGRADE APPROACH OF THE SFA. THE PHYSICIAN MAY HAVE UNKNOWINGLY RESTRICTED THE PORTION OF THE DEVICE NEAR THE HUB OF THE SHEATH WHICH POTENTIALLY CAUSED THE STENT TO EJECT FROM THE END OF THE DELIVERY SYSTEM AND NOT DEPLOY CORRECTLY THUS ONLY DEPLOYING 80MM OF THE 120MM. THE ENTIRETY OF THE STENT WAS DEPLOYED USING THE THUMB WHEEL.

  Patient problems: No Code Available

  MAUDE report 10501898 ↗
• MalfunctionFeb 2, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON THE GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AFTER A GUIDE WIRE CROSSED THE LESION, A 7X120X130MM INNOVA¿ STENT WAS SUCCESSFULLY IMPLANTED IN THE LESION. HOWEVER, UPON REMOVAL OF THE CATHETER OFF THE GUIDE WIRE, IT BECAME STUCK WITH THE WIRE. DURING REMOVAL, THE INNOVA SHAFT SEPARATED AND WAS REMOVED OVER THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7235912 ↗
• MalfunctionMay 25, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR 2134265-2017-05649. IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS STUCK ON THE WIRE. A 7 X 120 X 130 INNOVA¿ STENT WAS SELECTED FOR A LEFT SUPERFICIAL FEMORAL ARTERY (SFA) ANGIOPLASTY AND STENT PLACEMENT PROCEDURE. AFTER NORMAL STENT DEPLOYMENT, DURING REMOVAL OF THE STENT DELIVERY SYSTEM, THE STENT DELIVERY SYSTEM BECAME JAMMED ON THE V-18 CONTROL WIRE. THE GUIDEWIRE AND THE STENT DELIVERY SYSTEM HAD TO BE REMOVED TOGETHER. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT'S STATUS WAS REPORTED AS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591777 ↗

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