Innova™ Vascular H74939293072030Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729874157), received between Nov 21, 2016 and Jun 3, 2025 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Entrapment of Device; Fracture; Defective Device; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Fracture; Defective Device; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT FRACTURE OCCURRED, REQUIRING INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA ANTEGRADE APPROACH. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILD TO MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AFTER PRE-DILATION WITH 6X100 BALLOON, A 7 X 200 X 130 INNOVA SELF-EXPANDING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, RESISTANCE WAS ENCOUNTERED THROUGH THE SHEATH AND VESSEL. AFTER THE STENT WAS DEPLOYED, THERE WERE DIFFICULTIES IN REMOVING THE STENT DELIVERY SYSTEM. IT BECAME STUCK AND WAS UNABLE TO BE REMOVED FROM THE .14 THRUWAY WIRE. THE WHITE HANDLE WAS OPENED AND THE CATHETER WAS MANUALLY PULLED BACK TO REMOVE IT FROM THE BODY. UPON INSPECTION, A STENT FRAGMENT WAS STILL ATTACHED TO THE CATHETER, WHILE THE OTHER PORTION REMAINED INSIDE THE BODY. SUBSEQUENTLY, THE STENT APPEARED ELONGATED. ANOTHER 7X150X100 STENT WAS PLACED IN THE FRACTURED STENT STRUTS TO ENSURE APPOSITION AND POST DILATION WAS PERFORMED. THE FINAL ANGIOGRAPHY SHOWED BOTH STENTS ARE WELL APPOSED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132054 ↗
• InjuryNov 17, 2017Entrapment of Device; Stretched; Activation, Positioning or Separation Problem; Entrapment of Device; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND STRETCHED. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE APPROXIMATELY 70% STENOSED TARGET LESION LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A .014 THRUWAY 300CM GUIDEWIRE WAS ADVANCED AND A 45CM 7FR SHEATH WAS PLACED. PRE-DILATION WAS PERFORMED WITH A 6X200 BALLOON. A 7 X 200 X 130 INNOVA¿ STENT WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS INITIATED. THE THUMBWHEEL WAS USED UNTIL THE WHITE ARROW WAS VISIBLE. AFTER ABOUT 100MM, DEPLOYMENT STOPPED AND IT WOULD NOT MOVE. THE PULL GRIP WAS ATTEMPTED TO COMPLETE DEPLOYMENT, BUT IT WOULD NOT MOVE AND WAS STUCK. THE HANDLE WAS CRACKED OPEN TO ATTEMPT MANUAL DEPLOYMENT, BUT THIS WAS UNSUCCESSFUL. THE PHYSICIAN PULLED ON THE DEVICE TO REMOVE THE DEVICE FROM THE PATIENT. DURING THIS ATTEMPT, THE STENT DEPLOYED BUT WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH OTHER STENTS. TWO 6X150 NON-BSC STENTS WERE PLACED OVER THE INNOVA. THE PATIENT WAS FINE AND THERE WERE NO COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7041386 ↗
• MalfunctionNov 10, 2017Entrapment of Device; Stretched; Activation, Positioning or Separation Problem; Entrapment of Device; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THE STENT PARTIALLY DEPLOYED, ELONGATED AND DEVICE ENTRAPMENT ON GUIDEWIRE OCCURRED. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE 70% STENOSED TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY IN THE LOWER LEFT LEG. THE LESION WAS LIKELY PRE-DILATED AND A 7 X 200 X 130 INNOVA¿ STENT WAS SELECTED FOR A STENTING PROCEDURE. THE STENT WAS DEPLOYED FINE UNTIL ABOUT 60% DEPLOYED AFTER WHICH THE THUMBWHEEL AND PULL GRIP WOULD NOT WORK. THE GUIDEWIRE BECAME STUCK WITHIN THE INNOVA DEVICE. THE HANDLE WAS CRACKED OPEN TO ATTEMPT A 'BAIL OUT METHOD' TO COMPLETE DEPLOYMENT, BUT THAT DID NOT WORK. THE SYSTEM AS A WHOLE WAS PULLED AND THE STENT EVENTUALLY DEPLOYED. HOWEVER, THE STENT ELONGATED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7022915 ↗
• MalfunctionNov 7, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY PROPERLY. A 7 X 200 X 130 INNOVA¿ STENT WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE, WHILE INSIDE THE PATIENT, THE STENT FAILED TO DEPLOY PROPERLY AND THE MECHANISM FAILED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7008615 ↗
• InjuryOct 19, 2017Stretched; Activation, Positioning or Separation Problem; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT AND STENT ELONGATION OCCURRED. A 7 X 200 X 130 INNOVA¿ STENT WAS SELECTED FOR A PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING PRE-DILATION, THE STENT WAS ADVANCED CONTRALATERAL OVER A .035 UNKNOWN GUIDEWIRE AND STENT DEPLOYMENT WAS INITIATED. THE STENT WAS DEPLOYED 120MM WHEN THE STENT STRETCHED INTO THE ILIAC AND BECAME STUCK IN THE SHEATH OF THE DELIVERY SYSTEM. THE STENT WAS DEPLOYED AND THE DELIVERY SHEATH WAS REMOVED. THE PATIENT WAS SENT TO SURGERY THE NEXT DAY AND THE STENT WAS EXPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS WAS REPORTED AS FINE POST SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6963109 ↗
• MalfunctionSep 22, 2017Fracture; Fracture

  IT WAS REPORTED THAT A STENT FRACTURE OCCURRED. A 7X200X130 INNOVA¿ STENT WAS SUCCESSFULLY IMPLANTED IN THE COMMON FEMORAL-ILIAC ARTERY. THE STENT DELIVERY SYSTEM WAS REMOVED AND THE STENT WAS POST DILATED. THE PHYSICIAN THEN NOTED THAT THE STENT APPEARED FRACTURED. NO ADDITIONAL INTERVENTION WAS PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS FINE AND RECOVERING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6887240 ↗
• MalfunctionMar 23, 2017Stretched; Stretched

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 7 X 200 X 130 INNOVA¿ WAS SELECTED FOR USE AFTER ANOTHER INNOVA¿ WAS PREVIOUSLY DEPLOYED IN THE DISTAL SFA WITHOUT ISSUES. AFTER 150 CM OF THE 7 X 200 X 130 INNOVA¿ WAS DEPLOYED, THE REMAINING 50 CM OF THE STENT BEGAN TO ELONGATE. THIS CAUSED THE STENT TO GO FROM THE PROXIMAL SFA UP TO THE COMMON FEMORAL REGION COVERING THE PROFUNDA. THE PROCEDURE WAS COMPLETED WITH THIS STENT WITH NO INTERVENTION TAKEN TO THE STENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6429927 ↗
• InjuryMar 6, 2017Stretched; Activation, Positioning or Separation Problem; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DEPLOYMENT DIFFICULTY AND STENT ELONGATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 7 X 200 X 130 INNOVA¿ STENT WAS ADVANCED BUT WAS NOT ABLE TO BE FULLY DEPLOYED. THE PHYSICIAN CUT THE SHAFT OF THE DELIVERY SYSTEM FROM THE DEPLOYMENT HANDLE TO RELEASE THE STENT. THE STENT WAS ELONGATED. A NON-BSC STENT WAS DEPLOYED OVER THE INNOVA AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382121 ↗
• InjuryJan 19, 2017Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER FROZE ON THE WIRE AND THE CATHETER SHAFT DETACHED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 7 X 200 X 130 INNOVA¿ STENT WAS ADVANCED AND IMPLANTED. UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE PHYSICIAN HAD TO GIVE IT A TUG AS IT APPEARED TO STICK ON THE NON-BSC GUIDEWIRE NEAR THE SHEATH HUB OR IN THE SHEATH. THE INNER LUMEN OF THE INNOVA BROKE OFF AND REMAINED ON THE WIRE. THE PHYSICIAN USED A FORCEPS TO GRAB THE INNER LUMEN AND SUCCESSFULLY REMOVED IT OVER THE WIRE. WIRE ACCESS WAS MAINTAINED AND THE SAME WIRE WAS USED TO FINISH THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6264659 ↗
• InjuryDec 5, 2016Bent; Fracture; Activation, Positioning or Separation Problem; Bent; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A LEFT SUPERFICIAL FEMORAL ARTERY STENTING PROCEDURE, STENT DEPLOYMENT ISSUES AND STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE VERY MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 7MM-200MM/130CM INNOVA¿ STENT WAS ADVANCED OVER A .035 NON-BSC GUIDEWIRE TO THE TARGET LESION. THE PHYSICIAN TURNED THE THUMBWHEEL WITH NORMAL FORCE UNTIL THE WHITE ARROW WAS OBSERVED AND THEN PULLED THE BLUE PULL HANDLE BACK, BUT IT WOULD NOT GO FURTHER. THERE WAS STILL APPROXIMATELY 4MM OF THE STENT REMAINING ON THE DELIVERY SYSTEM. THEN WHILE ATTEMPTING TO PULL THE DELIVERY SYSTEM BACK TO RELEASE THE REMAINING PORTION OF THE STENT, THE STENT ELONGATED FROM 200MM TO APPROXIMATELY 300MM AND CAME OFF THE DELIVERY SYSTEM. THE STENT FRACTURED IN HALF. THE STENT WAS DEPLOYED WELL AND DID NOT JEOPARDIZE FLOW IN PROFUNDA. A 7X150 NON-BSC SELF-EXPANDING STENT WAS PUT ACROSS THE ELONGATED/FRACTURED SECTION OF THE STENT, AND ESSENTIALLY BRIDGED THE TWO GOOD ENDS OF THE STENT. 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 6145074 ↗
• MalfunctionDec 2, 2016Positioning Failure; Positioning Failure

  REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON 11 NOVEMBER 2016. IT WAS REPORTED THE STENT FAILED TO DEPLOY. DURING THE IMPLANTATION OF AN INNOVA 7 X 200 X 130 OVER AN .014 NON BSC FILTER WIRE. THE PHYSICIAN WAS USING THE THUMB WHEEL TO DELIVER THE DEVICE, AFTER APPROXIMATELY 15 CLICKS, THE STENT STILL HAD NOT BEGUN TO DEPLOY OUTSIDE OF THE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR A 7X150X130 INNOVA AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THE STENT IS PARTIALLY DEPLOYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6142256 ↗
• InjuryNov 21, 2016Bent; Break; Activation, Positioning or Separation Problem; Bent; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED, THE STENT ELONGATED, AND A PORTION OF THE STENT DETACHED. A 7 X 200 X 130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR A PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. AN ANTEGRADE APPROACH WAS USED. WHEN THEY WERE DEPLOYING THE STENT, THEY PULLED THE PIN TO RELEASE THE 200 LENGTH STENT. HOWEVER, THE LAST PORTION OF THE STENT BECAME HUNG UP WITHIN THE DELIVERY SYSTEM AND WOULD NOT RELEASE. THEY PULLED ON IT ASSUMING THAT THE STENT WOULD RELEASE ITSELF. RATHER, THE STENT ELONGATED AND A PORTION OF THE STENT DETACHED. THE PROXIMAL PORTION OF THE STENT WAS DETACHED FROM THE STENT ITSELF. THEY REMOVED THE DETACHED PIECE AND STENT THROUGH THE SHEATH. NOTHING WAS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. BALLOONED ANGIOPLASTY WAS PERFORMED IN THE REMAINING PORTION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6117044 ↗

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