Innova™ Vascular H74939293052030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729873976), received between Dec 2, 2016 and Oct 3, 2017 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2017Stretched; Activation, Positioning or Separation Problem; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT AND STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS PRE-DILATED WITH A 3MM COYOTE BALLOON CATHETER. A 5X200X130 INNOVA WAS SELECTED AND ADVANCED OVER A .035' NON BSC GUIDEWIRE VIA A CONTRALATERAL APPROACH TO THE TARGET LESION. THE PHYSICIAN NOTICED A DRAG WHILE ADVANCING THE DELIVERY SYSTEM. DEPLOYMENT WAS INITIATED AND THE STENT DEPLOYED 190MM. THE LAST 10MM WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. EVENTUALLY THE STENT WAS FULLY DEPLOYED BY THE PHYSICIAN PERFORMING A GENTLE TUG OF THE DELIVERY SYSTEM. IT WAS OBSERVED THAT THE LAST 10MM OF THE STENT WAS STRETCHED. AN ADDITIONAL 150MM INNOVA STENT WAS USED TO COVER THE STRETCHED PORTION OF THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6912955 ↗
• InjuryOct 3, 2017Difficult to Remove; Stretched; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Difficult to Remove; Stretched; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS FURTHER REPORTED THAT THE EVENT WAS REPORTED VIA A VOLUNTARY MEDWATCH # (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6912828 ↗
• InjurySep 11, 2017Bent; Occlusion Within Device; Stretched; Activation, Positioning or Separation Problem; Bent; Occlusion Within Device; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THERE WERE DEPLOYMENT ISSUES AND THE STENT BECAME DAMAGED RESULTING IN THROMBOSIS IN THE STENT AND AMPUTATION OF THE LIMB. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, HEAVILY CALCIFIED, LEFT SUPERFICIAL FEMORAL ARTERY (SFA). VASCULAR ACCESS WAS OBTAINED THROUGH A CONTRALATERAL APPROACH AND THE LESION WAS PRE-DILATED. A V-18 WIRE, 70MM 6 FR NON-BSC ACCESS SHEATH, AND 5 X 200 X 130 INNOVA¿ STENT WERE SELECTED FOR THE PROCEDURE. DEPLOYMENT WAS INITIATED AND NORMAL FORCE WAS REQUIRED TO TURN THE THUMBWHEEL. DURING DEPLOYMENT IN THE DISTAL PORTION OF THE ARTERY, THE OUTER SHEATH WAS NOT RETRACTING WITH THE THUMB CLICKS ON HANDLE. THE OUTER SHEATH WAS BARELY MOVING OFF OF THE LONG STENT. THE STENT WAS UNABLE TO DEPLOY THROUGH THE NORMAL MECHANISM OF THUMBWHEEL AND PULL GRIP AT AFTER ABOUT 60MM OF DEPLOYMENT. SO, THE PHYSICIAN ATTEMPTED A PIN AND PULL MECHANISM AND THE DISTAL 40-60MM OF THE STENT ACCORDIONED DOWN ON THE DISTAL PART OF THE VESSEL. THE PHYSICIAN WAS PULLING ON THE DEVICE AND WHEN HE WAS PULLING ON THE HANDLE, WAS ABLE TO REMOVE THE HANDLE AND THE OUTER SHEATH. THE OUTER STENT SHEATH CAME OUT AND THE INNER SILVER LINER REMAINED. TH

  Patient problems: Thrombosis

  MAUDE report 6854911 ↗
• InjuryJul 21, 2017Fracture; Stretched; Activation, Positioning or Separation Problem; Fracture; Stretched; Activation, Positioning or Separation Problem

  IT WAS FURTHER REPORTED THAT THIS EVENT WAS REPORTED VIA USER FACILITY MEDWATCH # (B)(4). MANUFACTURER MDR ID 2134265-2017-07723 IS A DUPLICATE OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6732529 ↗
• InjuryDec 16, 2016Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT DEPLOYMENT ISSUES AND STENT FRACTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) POPLITEAL. A 5MM-200MM/130CM INNOVA¿ STENT WAS ADVANCED TO THE TARGET LESION AND THE DISTAL PORTION OF THE STENT OPENED AT THE DISTAL SFA TOP LESION. WHILE CLICKING THE DEVICE ALL THE WAY THROUGH THE DELIVERY SYSTEM AND PULLING THE BLUE TANGENT, THE STENT WOULD NOT RELEASE FROM THE DELIVERY SYSTEM. IN AN ATTEMPT TO REMOVE THE DEVICE, THE STENT SNAPPED IN TWO. THE FOUR DISTAL MARKERS APPEARED IN THE ACCESS SHEATH. ANOTHER STENT WAS USED TO COMPRESS THE STENT UP AGAINST THE SIDE WALL OF THE ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6181382 ↗
• MalfunctionDec 2, 2016Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11-NOV-2016. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 5 X 200 X 130 INNOVA¿ STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING DEPLOYMENT, THE PHYSICIAN MADE ABOUT 30 CLICKS ON THE THUMB WHEEL BUT THE OUTER SHEATH WOULD NOT RETRACT. THE STENT WOULD NOT DEPLOY AND WAS NOT EXPOSED AT ALL. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT PARTIAL DEPLOYMENT AND SHAFT DETACHMENT/SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6141994 ↗

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