Innova™ Vascular H74939293086030Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729874188), received between Nov 21, 2016 and Apr 4, 2024 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2024Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A PARTIAL DEPLOYMENT OCCURRED. AN 8 X 60 X 130 INNOVA WAS SELECTED FOR DEPLOYMENT. DURING THE PROCEDURE, WHEN THE DEVICE WAS STENT TO DEPLOY, THE ROTATING MECHANISM THAT SIGNIFIES FULL DEPLOYMENT KEPT SPINNING. THE PHYSICIAN BELIEVED THAT THE DEVICE WAS FULLY DEPLOYED BUT WHEN THE DEVICE WAS WITHDRAWN, IT WAS IDENTIFIED THAT THE STENT GOT CAUGHT ON THE SHEATH WHEN TAKEN OUT. NO FURTHER INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC REGARDING THE PROCEDURE OR PATIENT STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19045244 ↗
• MalfunctionJan 3, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. AN 8 X 60 X 130 INNOVA VASCULAR STENT WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY STENTING. THE DEVICE WAS OPENED ON A STERILE FIELD. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE DISTAL TIP OF THE STENT HAD FLARED OUT. THE YELLOW SAFETY CLAMP WAS STILL ON THE DEVICE AND THE THUMB ROLLER WAS NOT TOUCHED. THE PLUNGER OF DEVICE WAS NOT PULLED OUT EITHER. THE DEVICE WAS IMMEDIATELY REMOVED FROM STERILE FIELD AND ANOTHER OF SAME DEVICE WAS OPENED AND DEPLOYED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440066 ↗
• MalfunctionDec 19, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY. AN 8.0X40X75CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT CAME OFF FROM THE BALLOON PRIOR TO DEPLOYMENT. AN 8 X 60 X 130 INNOVA VASCULAR STENT WAS USED TO TRAP THE EXPRESS LD STENT UP AGAINST THE WALL VESSEL. HOWEVER, THE INNOVA STENT DID NOT REACH THE DESIRED TARGET AREA FOR PLACEMENT. THE PHYSICIAN PLANS TO SEND BACK THE PATIENT TO STENT THE INTENDED AREA. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360742 ↗
• InjuryDec 11, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED BRACHIAL ARTERY AND A SHOCKWAVE DEVICE WAS PERFORMED. AN 8.0X30X75CM EXPRESS LD STENT BALLOON EXPANDABLE WAS CROSSED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS PULLED BACK TO BE REPOSITIONED FOR MORE PRECISION, THE STENT SLID OFF OF THE STENT BALLOON CATHETER, THUS DISLODGED INSIDE THE PATIENT. THE DEVICE WAS TAKEN OUT BY SNARING THROUGH THE FEMORAL ARTERY AND WAS FULLY RECOVERED. THERE WERE NO FRAGMENTS LEFT INSIDE THE BODY AND THE PROCEDURE WAS COMPLETED VIA ANGIOPLASTY WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302811 ↗
• MalfunctionFeb 3, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 8 X 60 X 130 INNOVA VASCULAR STENT WAS SELECTED FOR USE. DURING UNPACKING, THE STENT WAS ALREADY EXPOSED. THE CLIP WAS STILL ON THE DEVICE. THE DEVICE COULD NOT BE PREPPED AS THE STENT WAS NOT IN THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER INNOVA STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292534 ↗
• MalfunctionJul 8, 2022Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15JUN2022. IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO ADVANCE. A 8 X 60 X 130 INNOVA WAS SELECTED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING INSERTION, THE DEVICE WAS DIFFICULT TO ADVANCE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED STENT PREMATURE DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958789 ↗
• MalfunctionFeb 18, 2022Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THERE WAS DIFFICULTY REMOVING THE STENT DELIVERY SYSTEM. A 8X60X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE IN THE SUBCLAVIAN ARTERY. THE STENT WAS DEPLOYED SUCCESSFULLY. UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE SYSTEM WAS DIFFICULT TO REMOVE FROM THE NON-BOSTON SCIENTIFIC GUIDEWIRE. A HEMOSTAT WAS APPLIED TO THE OUTER BLUE SHEATH LINING TO HELP WITH THE REMOVAL OF THE DEVICE OFF OF THE WIRE. AFTER THE STENT DELIVERY SYSTEM WAS REMOVED, THE THUMBWHEEL WAS VISIBLY LOOSE AND FELL INTO THE BODY OF THE HANDLE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559691 ↗
• InjuryApr 15, 2021Difficult or Delayed Positioning; Fracture; Material Deformation; Activation Failure; Difficult or Delayed Positioning; Fracture; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO DEPLOY AND WAS DEFORMED, FRACTURED AND FAILED TO EXPAND. AN 8X60X130 INNOVA VASCULAR SELF EXPANDING STENT WAS SELECTED FOR USE IN A PROCEDURE IN THE EXTERNAL ILIAC ARTERY. DURING THE PROCEDURE, THE USER NOTED THE THUMBWHEEL WAS OPERATING DIFFERENTLY THAN EXPECTED AND UPON DEPLOYMENT, IT WAS APPARENT THE STENT WAS NOT PROPERLY EXPANDING. ADDITIONALLY, PER IMAGING, THE STENT APPEARED TO BE BROKEN IN TWO PIECES. A SECOND INNOVA STENT WAS PLACED TO LINE THE ORIGINAL STENT. UPON POST DILATION IT WAS CONFIRMED THAT THE INITIAL INNOVA STENT WAS ELONGATED BASED ON A 60MM BALLOON BEING USED FOR POST DILATION, AND THE STENT BEING AT LEAST 10MM SHORTER THAN THAT BALLOON. IT WAS REPORTED THAT THE PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675080 ↗
• MalfunctionDec 15, 2016Bent; Activation, Positioning or Separation Problem; Bent; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A LEFT EXTERNAL ILIAC ARTERY ANGIOPLASTY AND STENTING PROCEDURE, STENT DEPLOYMENT ISSUES AND STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A CONTRALATERAL APPROACH. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT EXTERNAL ILIAC ARTERY. AFTER PREDILATION, A 8MM-60MM/130CM INNOVA¿ STENT WAS ADVANCED TO THE TARGET LESION. THE THUMBWHEEL WAS TURNED WITH NORMAL FORCE BUT IT LOCKED UP WHEN THE STENT WAS DEPLOYED ABOUT 30MM. THE PULL GRIP WAS USED BUT IT ALSO LOCKED UP AND WOULD NOT DEPLOY THE LAST HALF OF THE STENT. THE STENT WAS PULLED OUT OF THE BODY AND IT WAS STRETCHED. THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6175689 ↗
• InjuryNov 21, 2016Fracture; Fracture

  IT WAS REPORTED DURING A PERIPHERAL INTERVENTION OF A VEIN BYPASS GRAFT, STENT FRACTURE AND VESSEL PERFORATION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL POPLITEAL ARTERY UTILIZING CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VEIN BYPASS GRAFT WITH A REFERENCE VESSEL DIAMETER OF 7MM. AFTER A NON-BSC GUIDEWIRE WAS PASSED THROUGH AND PRE-DILATION WAS PERFORMED USING A 5X40MM MUSTANG BALLOON, A 8X60X130 INNOVA¿ STENT WAS ADVANCED TO THE TARGET LESION. THUMBWHEEL WAS TURNED WITH NORMAL FORCE. POST STENT PLACEMENT, IT WAS NOTED THAT THE STENT FRACTURED BUT STILL REMAINED AS ONE PIECE. VESSEL PERFORATION WAS CONFIRMED BY MULTIPLE ANGIOGRAPHIC IMAGES. ANOTHER 8X50 NON-BSC STENT WAS PLACED TO COVER THE LESION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE AT THIS TIME.

  Patient problems: Perforation of Vessels

  MAUDE report 6116841 ↗

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