Innova™ Vascular H74939293074030Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729874089), received between Feb 7, 2017 and Apr 12, 2023 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (9 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.

• MalfunctionApr 12, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE INNOVA INADVERTENTLY DEPLOYED OUTSIDE OF THE PATIENT. AN INNOVA VASCULAR WAS SELECTED FOR USE. DURING DEVICE PREPARATION, THE STENT INADVERTENTLY DEPLOYED OUTSIDE OF THE PATIENT. THE INNOVA WAS REPLACED WITH ANOTHER INNOVA IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728597 ↗
• MalfunctionMar 6, 2023Difficult to Insert; Premature Activation; Device-Device Incompatibility; Difficult to Insert; Premature Activation; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 7 X 40 X 130 INNOVA VASCULAR SELF-EXPANDING STENT WAS SELECTED FOR USE. AFTER A NON-BOSTON SCIENTIFIC BALLOON RUPTURED AND A POSSIBLE FRAGMENT BROKE OFF, IT WAS DECIDED TO PIN THE FRAGMENT WITH A STENT IN THE SUPERFICIAL FEMORAL ARTERY. UPON INSERTION INTO THE 7FR SHEATH, THERE WAS RESISTANCE. THE STENT COULD NOT BE ADVANCED IN THE SHEATH AND WAS REMOVED. UPON REMOVAL, THE PHYSICIAN WAS CHECKING THE TIP TO SEE IF THERE WAS AN ISSUE WITH THE DEPLOYMENT SYSTEM AND PARTIALLY DEPLOYED THE STENT IN DOING SO. UPON REMOVING THE STENT OFF THE GUIDEWIRE, THE DEPLOYMENT SYSTEM WAS PULLED, COMPLETELY DEPLOYING THE STENT. AFTER FURTHER INVESTIGATION, THE NON-BOSTON SCIENTIFIC BALLOON WAS FOUND LODGED IN THE SHEATH. THE PROCEDURE WAS COMPLETED WITHOUT A STENT. WHILE IT WAS ORIGINALLY PLANNED TO JAIL A PIECE OF THE BALLOON THAT BROKE OFF JUST OUTSIDE THE SHEATH, THE STENT WAS NOT NEEDED SINCE THE BALLOON AND BALLOON SHAFT WAS FOUND JAMMED INSIDE THE SHEATH. THE SHEATH AND BALLOON WERE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485798 ↗
• MalfunctionDec 26, 2022Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 7 X 40 X 130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE IN A VASCULAR INTERVENTION. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE 99% STENOSED TARGET LESION THAT WAS SEVERELY CALCIFIED AND LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE LESION WAS PRE-DILATED WITH A BALLOON, BUT THE INNOVA WOULD NOT CROSS THE LESION. THE DEVICE WAS REMOVED. THE STENT LOOKED DEFECTIVE; IT LOOKED LIKE THE MIDDLE CATHETER HAD COME BACK, SO THE DISTAL TIP OF THE STENT WAS EXPOSED. ANOTHER INNOVA STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048585 ↗
• MalfunctionSep 30, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. VASCULAR ACCESS WAS GAINED VIA CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 7 X 40 X 130 INNOVA VASCULAR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT DEPLOYED AFTER TWO CLICKS. A 7X60 INNOVA WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15512752 ↗
• MalfunctionJun 28, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 7 X 40 X 130 INNOVA WAS SELECTED FOR USE. DURING UNPACKING, THE STENT WAS STICKING OUT OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840804 ↗
• MalfunctionApr 2, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THE STENT PREMATURELY DEPLOYED. A 7X40X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE AND A CONTRALATERAL APPROACH WAS PERFORMED. WHILE DELIVERING THE STENT INSIDE THE PATIENT, THE STENT PREMATURELY DEPLOYED IN THE RIGHT COMMON FEMORAL ARTERY. THIS WAS NOT THE DESIRED DEPLOYMENT LOCATION. IT WAS NOTED THE LOCKING TOOL WAS IN PLACE THE ENTIRE TIME. NO FURTHER INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS AND FLOW WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610636 ↗
• MalfunctionAug 26, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 7 X 40 X 130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR A PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING PREPARATION, THE INNOVA STENT WAS HALF DEPLOYED WHEN THE PACKAGE WAS OPENED. THE DEVICE DID NOT ENTER THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER INNOVA DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8930510 ↗
• InjuryMar 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STENT FORESHORTENED. A 7X40X130 INNOVA SELF EXPANDING STENT WAS SELECTED TO TREAT A LESION DURING A PERIPHERAL ANGIOPLASTY PROCEDURE. ONCE THE STENT WAS DEPLOYED IT WAS OBSERVED THAT THE STENT DRAMATICALLY FORESHORTENED ON THE PROXIMAL END. ADDITIONAL STENTING WAS REQUIRED TO FULLY COVER THE LESION. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS AND THE PATIENT RECOVERED AND WAS DISCHARGED. ADDITIONAL INFORMATION REPORTED THAT THERE WAS NO DIFFICULTY IN THE DEPLOYMENT. THE STENT SHORTENED 1/2 CM. THE LESION WAS 98% STENOSED IN THE HIGHLY CALCIFIED MID SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS PRE-DILATED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8403877 ↗
• MalfunctionOct 5, 2018Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. ACCESS WAS GAINED VIA THE LEFT FEMORAL, WITH A 6 FRENCH SHEATH, FOR AN IN STENT RESTENOSIS TREATMENT PROCEDURE FROM THE SUPERFICIAL FEMORAL ARTERY (SFA) TO THE PROXIMAL POPLITEAL. THE PHYSICIAN ATTEMPTED TO ADVANCE 2 SEPARATE INNOVA STENTS OVER A NON BSC GUIDEWIRE BUT THE STENTS STARTED TO DEPLOY BEFORE ENTERING THE HUB OF THE SHEATH FROM THE FORCE REQUIRED TO ADVANCE THE STENT DELIVERY SYSTEM OVER THE NON BSC GUIDEIRE. NEITHER STENT ENTERED THE SHEATH OR THE BODY OF THE PATIENT. THE PHYSICIAN WAS ABLE TO IMPLANT A NON BSC STENT AND POST-DILATED WITH A POBA BALLOON. THE CASE WAS COMPLETED WITH A GOOD OUTCOME AND THE PATIENT IS DOING WELL. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN INNOVA SELF-EXPANDING STENT DELIVERY SYSTEM (SDS). THE OUTER SHEATH, MID-SHAFT, AND THE REMAINDER OF THE DEVICE WERE CHECKED FOR DAMAGE. VISUAL EXAMINATION SHOWED A KINK AT THE NOSECONE. IT WAS NOTICED THAT THE STENT WAS NOT IN THE DEVICE IT WAS RETURNED IN THE BAG. THE YELLOW THUMBWHEEL LOCK WAS INTACT ON THE DEVICE. THE PULL HANDLE WAS AT THE START POSITION. THE CIS INVESTIGATOR ROTATED THE THUMBWHEEL TO VERIFY FUNCTIONALITY OF THE DEV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7938584 ↗
• MalfunctionJan 11, 2018Bent; Premature Activation; Bent; Premature Activation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED AND BECAME DAMAGED. THE PATIENT PRESENTED WITH A CHRONIC TOTAL OCCLUDED (CTO) LESION IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING PRE-DILATION, A 7 X 40 X 130 INNOVA¿ WAS ADVANCED CONTRALATERAL HOWEVER THE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO PASS THROUGH THE OSTIUM OF THE LESION. AT THAT TIME, THE DISTAL STENT BEGAN TO PREMATURELY DEPLOY FROM THE SDS AND THE STENT BECAME SLIGHTLY LIFTED. THE STENT REMAINED IN THE SDS AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7183346 ↗
• InjuryJul 18, 2017Bent; Activation, Positioning or Separation Problem; Bent; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 7X40X130MM INNOVA¿ STENT WAS SELECTED TO TREAT THE LESION. THE STENT APPEARED ¿CRUMPLED¿ UPON DEPLOYMENT AND COULD NOT BE FULLY DEPLOYED. THE STENT EVENTUALLY DEPLOYED AND THE PHYSICIAN THEN IMPLANTED A 7X150MM STENT TO COVER THE AREA OF THE INNOVA¿ THAT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6723030 ↗
• MalfunctionFeb 7, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT DEPLOYMENT DIFFICULTY OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A CONTRALATERAL APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). AFTER CROSSING A NON-BSC GUIDEWIRE, INTRAVASCULAR ULTRASOUND WAS USED. AFTER PREDILATION WITH A NON-BSC BALLOON CATHETER, A 7MM-40MM/130CM INNOVA¿ STENT WAS DELIVERED, BUT RESISTANCE WAS FELT IN THE DISTAL TIP AT THE ENTRANCE PART OF THE SHEATH. WHEN IT WAS ADVANCED AS IT IS, THE STENT WAS PROTRUDED AWAY OUTSIDE THE PATIENT'S BODY, AND THE BLUNTED STENT WAS FOUND HANGING IN THE SHAFT OF THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE OUTER SHEATH WAS HARDLY MOVING AND THE STOPPER OF THE THUMBWHEEL WAS ALSO NOT REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 7MM-40MM/75CM INNOVA STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6308779 ↗

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