Innova VascularRecalls & reported problems across all models

We found 42 models of Innova Vascular by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 302 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Jul 28, 2026 — classified as 4 deaths, 91 injuries, 207 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (93 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Innova Vascular problems

Innova Vascular models

42 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Innova™ Vascular H74939293062030

  STENT, SUPERFICIAL FEMORAL ARTERY
  38 reports
• Innova™ Vascular H74939293061530

  STENT, SUPERFICIAL FEMORAL ARTERY
  24 reports
• Innova™ Vascular H74939293051530

  STENT, SUPERFICIAL FEMORAL ARTERY
  20 reports
• Innova™ Vascular H74939293064030

  STENT, SUPERFICIAL FEMORAL ARTERY
  16 reports
• Innova™ Vascular H74939293071530

  STENT, SUPERFICIAL FEMORAL ARTERY
  16 reports
• Innova™ Vascular H74939293066030

  STENT, SUPERFICIAL FEMORAL ARTERY
  12 reports
• Innova™ Vascular H74939293074030

  STENT, SUPERFICIAL FEMORAL ARTERY
  12 reports
• Innova™ Vascular H74939293072030

  STENT, SUPERFICIAL FEMORAL ARTERY
  12 reports
• Innova™ Vascular H74939293054030

  STENT, SUPERFICIAL FEMORAL ARTERY
  11 reports
• Innova™ Vascular H74939293061030

  STENT, SUPERFICIAL FEMORAL ARTERY
  11 reports
• Innova™ Vascular H74939293076030

  STENT, SUPERFICIAL FEMORAL ARTERY
  11 reports
• Innova™ Vascular H74939293061830

  STENT, SUPERFICIAL FEMORAL ARTERY
  10 reports
• Innova™ Vascular H74939293086030

  STENT, SUPERFICIAL FEMORAL ARTERY
  10 reports
• Innova™ Vascular H74939293071230

  STENT, SUPERFICIAL FEMORAL ARTERY
  7 reports
• Innova™ Vascular H74939293084030

  STENT, SUPERFICIAL FEMORAL ARTERY
  7 reports
• Innova™ Vascular H74939293052030

  STENT, SUPERFICIAL FEMORAL ARTERY
  6 reports
• Innova™ Vascular H74939293061230

  STENT, SUPERFICIAL FEMORAL ARTERY
  6 reports
• Innova™ Vascular H74939293051230

  STENT, SUPERFICIAL FEMORAL ARTERY
  5 reports
• Innova™ Vascular H74939293068030

  STENT, SUPERFICIAL FEMORAL ARTERY
  5 reports
• Innova™ Vascular H74939293071030

  STENT, SUPERFICIAL FEMORAL ARTERY
  5 reports
• Innova™ Vascular H74939293071830

  STENT, SUPERFICIAL FEMORAL ARTERY
  5 reports
• Innova™ Vascular H74939293088030

  STENT, SUPERFICIAL FEMORAL ARTERY
  5 reports
• Innova™ Vascular H74939293064070

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• Innova™ Vascular H74939293084070

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• Innova™ Vascular H74939293051030

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• Innova™ Vascular H74939293078030

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• Innova™ Vascular H74939293061570

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• Innova™ Vascular H74939293081070

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 deaths3 reports
• Innova™ Vascular H74939293070230

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• Innova™ Vascular H74939293080230

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• Innova™ Vascular H74939293081230

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• Innova™ Vascular H74939293061870

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• Innova™ Vascular H74939293074070

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• Innova™ Vascular H74939293086070

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• Innova™ Vascular H74939293056030

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• Innova™ Vascular H74939293060230

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• Innova™ Vascular H74939293081530

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• Innova™ Vascular H74939293061070

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• Innova™ Vascular H74939293078070

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 death1 report
• Innova™ Vascular H74939293071570

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• Innova™ Vascular H74939293088070

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• Innova™ Vascular H74939293058030

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report

Recent Innova Vascular adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060365 ↗
• MalfunctionJul 22, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25907172 ↗
• MalfunctionJul 20, 2026Fracture

  IT WAS REPORTED THAT THE STENT FRACTURED OCCURRED.A 5 X 60 X 130 INNOVA STENT SELF EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS DEPLOYED, HOWEVER, THE DEVICE FRACTURED DURING DEPLOYMENT AND WAS RETRACTED AND REMOVED FROM THE PATIENT. A REPLACEMENT INNOVA STENT WAS THEN USED, BUT THE SAME ISSUE OCCURRED. A THIRD INNOVA STENT WAS SUBSEQUENTLY OPENED AND DEPLOYED SUCCESSFULLY, ALLOWING THE PROCEDURE TO BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883625 ↗
• MalfunctionJul 13, 2026Fracture

  IT WAS REPORTED THAT THE STENT FRACTURED OCCURRED. A 5 X 60 X 130 INNOVA STENT SELF EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS DEPLOYED, HOWEVER, THE DEVICE FRACTURED DURING DEPLOYMENT AND WAS RETRACTED AND REMOVED FROM THE PATIENT. A REPLACEMENT INNOVA STENT WAS THEN USED, BUT THE SAME ISSUE OCCURRED. A THIRD INNOVA STENT WAS SUBSEQUENTLY OPENED AND DEPLOYED SUCCESSFULLY, ALLOWING THE PROCEDURE TO BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25796562 ↗
• MalfunctionApr 15, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem; Packaging Problem

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6 X 100 X 130 INNOVA STENT SELF EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN INNOVA WAS ADVANCED OVER THE WIRE WITH THE YELLOW SAFETY LOCK IN PLACE, IT WAS NOTED THAT 5 MILLIMETERS (MM) OF THE STENT WAS DEPLOYED, AND THAT THE PARTIAL DEPLOYMENT OCCURRED OUTSIDE THE PATIENT. IT WAS ALSO REPORTED THAT THE PACKAGE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885645 ↗
• InjuryApr 8, 2026Nonstandard Device; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE STENT APPEARED SHORTER THAN EXPECTED, REQUIRING AN ADDITIONAL DEVICE. THE TARGET LESION WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. A 6 X 150 X 130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE DEPLOYED STENT LENGTH APPEARED SHORTER THAN ANTICIPATED BUT PROCEEDED WITH DEPLOYMENT. ONCE FULLY RELEASED WITHIN THE VESSEL, THE STENT CONTINUED TO PRESENT AS SHORTER THAN EXPECTED. THIS OBSERVATION WAS FURTHER SUBSTANTIATED WHEN A 5 X 150 CHARGER BALLOON WAS ADVANCED TO THE LESION AND FOUND TO BE SIGNIFICANTLY LONGER THAN THE STENT IN PLACE. IT WAS SUBSEQUENTLY SUSPECTED THAT THE STENT DEPLOYED, LABELED AS A 6 X 150, MAY HAVE ACTUALLY BEEN A 6 X 100. THE INTERVENTION WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817808 ↗
• MalfunctionDec 22, 2025Nonstandard Device; Incomplete or Missing Packaging; Nonstandard Device; Incomplete or Missing Packaging

  IT WAS REPORTED THAT PROFILE PROBLEM AND LABELING ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RIGHT ILIAC ARTERY. A 8 X 120 X 130 INNOVA VASCULAR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS DEPLOYED AND A 7X150 RANGER BALLOON WAS USED FOR POST-DILATION. IT WAS OBSERVED THAT THE STENT APPEARED TO BE LONGER THAN THE BALLOON, RESULTING IN A LONGER STENT THAN INTENDED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866819 ↗
• 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 ↗
• MalfunctionNov 6, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. A 5 X 40 X 130 INNOVA SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PREPARATION, THE STENT APPEARED TO BE PARTIALLY DEPLOYED AFTER FLUSHING THE BACK END. IT WAS UNCERTAIN WHETHER THE STENT WAS ALREADY PARTIALLY DEPLOYED PRIOR TO FLUSHING OR IF THE FLUSHING PROCESS CAUSED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486669 ↗
• MalfunctionOct 27, 2025Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY. A 6 X 60 X 130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, THE STENT STARTED TO DEPLOY WHILE BEING LOADED ONTO THE WIRE, BEFORE ENTERING THE PATIENT'S BODY. THE YELLOW SAFETY MECHANISM WAS STILL IN PLACE. THE STENT DID NOT ENTER THE PATIENT'S BODY AND WAS REMOVED FROM THE WIRE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23395153 ↗
• 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 ↗
• MalfunctionJul 8, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED PERIPHERAL ARTERY. A 6 X 200 X 130 INNOVA? VASCULAR STENT WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS DEPLOYED BY ABOUT 1MM BUT COULD NOT BE FULLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER INNOVA STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437236 ↗
• MalfunctionJun 23, 2025Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED, AND THE STENT STRETCHED. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE CHRONIC TOTAL OCCLUSION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6 X 200 X 130 INNOVA VASCULAR STENT WAS ADVANCED FOR PERIPHERAL ARTERY DISEASE TREATMENT. DURING THE PROCEDURE, THIS STENT WAS DIFFICULT TO DEPLOY; ONLY 6CM DEPLOYED WHEN IT WOULD NO LONGER DEPLOY ALL THE WAY, EVEN WHEN THE PULL GRIP WAS UTILIZED. SUBSEQUENTLY, THE HANDLE WAS TAKEN APART IN ORDER TO COMPLETE STENT DEPLOYMENT. HOWEVER, AS A RESULT OF THIS EVENT, THE STENT STRETCHED APPROXIMATELY 100 MM. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310251 ↗
• 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 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED VIA MEDWATCH#: MW5169162 THAT THE DEVICE BROKE OFF. A 7 X 60 X 130 INNOVA VASCULAR SELF-EXPANDING STENT WAS ADVANCED FOR TREATMENT. AFTER STENT DEPLOYMENT, THE DEVICE WAS REMOVED AND FOUND THAT THE STENT DELIVERY SYSTEM BROKE OFF IN THREE PIECES IN THE BODY. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090044 ↗

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