Innova™ Vascular H74939293076030Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729874096), received between May 19, 2017 and May 27, 2025 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryApr 24, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED, REQUIRING SURGICAL INTERVENTION FOR REMOVAL. A 7 X 60 X 130 INNOVA? VASCULAR STENT WAS TO TREAT CHRONIC LIMB ISCHEMIA (CLI). DURING THE PROCEDURE, THE PHYSICIAN USED TWO ACCESS SITES TO THE TARGET LOCATION. A 6F NON-BOSTON SCIENTIFIC SHEATH WAS ADVANCED OVER A .035 GLIDEWIRE ADVANTAGE TO DEPLOY THE INNOVA STENT. DURING DEPLOYMENT, THE TIP OF THE STENT FRACTURED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DETACHED STENT TIP THROUGH ACCESS IN THE TIBIAL OR PEDAL ARTERY WITH A 5FR SHEATH. A RANGER BALLOON WAS ADVANCED; HOWEVER, IT BECAME KINKED. SURGICAL INTERVENTION WAS PERFORMED TO ACCESS THE DETACHED STENT. THE STENT WAS PARTIALLY EXPLANTED, AND A PORTION REMAINS IMPLANTED. THE PROCEDURE WAS THEN COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO COMPLICATIONS RESULTING FROM THIS EVENT, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901300 ↗
• InjuryDec 10, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT AND OVERSTIMULATION OCCURRED, REQUIRING MEDICAL INTERVENTION. THE STENOSED TARGET LESION WAS LOCATED IN THE FISTULA. A 7 X 60 X 130 INNOVA VASCULAR WAS SELECTED FOR USED IN A PROCEDURE VIA ARM APPROACH. HOWEVER, DURING THE STENT DEPLOYMENT, THE STENT PREMATURELY DEPLOYED AND WAS INCORRECTLY POSITIONED, FLOATING FREELY WITHIN THE BLOOD VESSEL. THE PHYSICIAN ATTEMPTED TO RESOLVE THE ISSUE BY USING A SECOND STENT TO TRAP THE FIRST ONE, BUT THIS WAS UNSUCCESSFUL. CONSEQUENTLY, THE PATIENT'S ELECTROCARDIOGRAM (EKG) CHANGED, AND THE PATIENT EXPERIENCED OVERSTIMULATION. THE PATIENT WAS THEN SENT TO THE EMERGENCY ROOM FOR FURTHER TREATMENT. IT WAS FURTHER REPORTED THAT THE STENT WAS BEING PLACED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). ADDITIONALLY, THE PHYSICIAN DID NOT ATTEMPT TO DEPLOY THE STENT BEFORE IT DEPLOYED PREMATURELY IN THE SFA. THE STENT REMAINS IN THE PATIENT.

  Patient problems: Device Overstimulation of Tissue; Foreign Body In Patient; Perforation of Vessels

  MAUDE report 20893403 ↗
• MalfunctionAug 6, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. AN INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE IN A REVASCULARIZATION PROCEDURE. DURING PREPARATION, THE DEVICE PRE-DEPLOYED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921697 ↗
• InjuryJan 19, 2022Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. VASCULAR ACCESS WAS GAINED WITH CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). A 7 X 60 X 130 INNOVA STENT WAS SELECTED FOR USE. THE INNOVA WAS IN THE APPROPRIATE POSITION PRIOR TO DEPLOYMENT. THE STENT WAS DEPLOYED; HOWEVER, THE STENT MOVED FORWARD OR WAS SHORT OF THE DESIRED POSITION. AN EXPRESS 7 X 17 DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13296293 ↗
• MalfunctionJan 4, 2021Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE GUIDEWIRE AND PARTIALLY DEPLOYED OUTSIDE THE PATIENT. AN INNOVA WAS SELECTED FOR USE IN A STENTING PROCEDURE TO TREAT A DISSECTION FLAP IN THE SUPERFICIAL FEMORAL ARTERY. UPON PLACING THE STENT ON A 0.035 INCH STIFF ZIPWIRE GUIDEWIRE, THE DEVICE BECAME STUCK. AN ATTEMPT WAS MADE TO TAKE THE STENT OFF THE WIRE TO RE-FLUSH, BUT IN DOING SO, THE STENT PARTIALLY DEPLOYED OUTSIDE THE BODY. THE STENT NEVER ENTERED THE BODY. EVENTUALLY, THE DEVICE WAS ABLE TO BE REMOVED FROM THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11108327 ↗
• MalfunctionJul 15, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. A 7X60X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE ON A CALCIFIED AND TORTUOUS VASCULATURE. THE INNOVA DELIVERY SYSTEM WAS ADVANCED OVER THE WIRE TO THE TARGET LESION. THE PHYSICIAN WANTED TO REPOSITION THE DEVICE, AND DURING THIS ATTEMPT THE STENT BEGAN TO PREMATURELY DEPLOY, APPROXIMATELY 10MM OF THE STENT BECAME EXPOSED. THE ENTIRE DELIVERY CATHETER WITH THE PARTIALLY EXPOSED STENT WAS REMOVED OVER THE WIRE FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A 7X80 INNOVA DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8790159 ↗
• InjuryNov 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID# 2134265-2017-10896 , 2134265-2017-10894, 2134265-2017-10897, 2134265-2017-10898. IT WAS REPORTED THAT A PERFORATION OCCURRED. THE PATIENT PRESENTED VERY ILL. THE PATIENT WAS BEING TREATED FOR BI-LATERAL ILIAC ARTERY RECANALIZATION. VASCULAR ACCESS WAS GAINED VIA THE RIGHT POPLITEAL ARTERY WITH A 6F SHEATH. THE ILIAC ARTERY WAS THEN CROSSED WITH A NON BSC GUIDEWIRE AND A SUPPORT CATHETER. PRE-DILATION WAS PERFORMED USING A 4X60MM MUSTANG BALLOON CATHETER. AN EXPRESS LD 6X40 STENT WAS IMPLANTED ALONG WITH TWO INNOVA STENTS (7X60MM AND 7X80MM) IN BOTH THE RIGHT EXTERNAL ILIAC ARTERY AND THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN THEN WENT TO TAKE IMAGES AND NOTICED BLEEDING IN THE RIGHT EXTERNAL ILIAC ARTERY AND SUSPECTED A PERFORATION. THE PERFORATION WAS TREATED WITH 2 NON BSC COVERED STENTS ALONG WITH MULTIPLE PROLONGED ANGIOPLASTY BALLOON INFLATIONS TO CONTROL THE BLEED. ONCE THE BLEEDING WAS CONTROLLED, THE PHYSICIAN WENT TO REMOVE THE SHEATH FROM THE POPLITEAL ARTERY WHEN CLOTTING WAS THEN OBSERVED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN TRIED TO ASPIRATE THE CLOT THROUGH THE SHEATH, AND THEN BY USING A GUIDE CATHETER, WITHOUT SUCCESS.

  Patient problems: Perforation of Vessels

  MAUDE report 7023007 ↗
• MalfunctionJul 11, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR ID: 2134265-2017-06682 IT WAS REPORTED THAT THE CATHETER BECAME STUCK ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 7 X 60 X 130 INNOVA¿ STENT WAS SELECTED FOR USE. THE STENT DELIVERY SYSTEM (SDS) BECAME STUCK ON THE GUIDEWIRE WHEN IT WAS BEING REMOVED FROM THE PATIENT. WIRE ACCESS WAS LOST. A SECOND 7 X 60 X 130 INNOVA¿ STENT WAS THEN SELECTED FOR USE; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD 7 X 60 X 130 INNOVA¿ STENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6701965 ↗
• MalfunctionJul 11, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR ID: 2134265-2017-06681. IT WAS REPORTED THAT THE CATHETER BECAME STUCK ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 7 X 60 X 130 INNOVA STENT WAS SELECTED FOR USE. THE STENT DELIVERY SYSTEM (SDS) BECAME STUCK ON THE GUIDEWIRE WHEN IT WAS BEING REMOVED FROM THE PATIENT. WIRE ACCESS WAS LOST. A SECOND 7 X 60 X 130 INNOVA STENT WAS THEN SELECTED FOR USE; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD 7 X 60 X 130 INNOVA STENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6701957 ↗
• InjuryMay 19, 2017Activation Failure; Activation Failure

  SAME CASE AS MDR ID:2134265-2017-04811. IT WAS REPORTED TWO STENTS FAILED TO EXPAND. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. USING A CONTRALATERAL APPROACH, THE PHYSICIAN ADVANCED A 7 X 60 X 130 INNOVA STENT AND DEPLOYED BUT FAILED TO EXPAND. A SECOND 7 X 40 X 75 INNOVA STENT WAS THEN ADVANCED AND DEPLOYED BUT ALSO FAILED TO EXPAND. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE BY POST DILATING THE STENTS WITH BALLOON ANGIOPLASTY. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6579194 ↗

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