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Innova™ Vascular H74939293088070Recalls & reported problems

Boston Scientific Corporation · Self-Expanding Stent System · Class 3 · Implant

All models of Innova Vascular (42)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729873839), received between Aug 24, 2023 and Aug 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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

Device problems

  • Activation, Positioning or Separation Problem1
  • Adverse Event Without Identified Device or Use Problem1
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 24, 2023Fracture; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Fracture; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED AND BECAME FRACTURED. THIS 8 X 80 X 75 INNOVA VASCULAR STENT WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY (SFA) STENTING PROCEDURE. THE 70% STENOSED SFA LESION WAS MILDLY CALCIFIED AND MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN BELIEVED THE STENT WAS FULLY DEPLOYED USING THE THUMBWHEEL; THEREFORE, PULLED ON THE CATHETER TO REMOVE IT, BUT FELT RESISTANCE. AT THAT TIME, THEY FELT A BREAK IN THE STENT AT THE PROXIMAL SFA. POST DILATION OF THE LESION WAS PERFORMED, AND THE BROKEN PIECE OF STENT WAS REMOVED WHICH WAS STILL ATTACHED TO THE CATHETER. A PORTION OF THE STENT REMAINED IMPLANTED. ADDITIONALLY, IT WAS THOUGHT THAT THE STENT HAD NOT BEEN FULLY DEPLOYED BEFORE PULLING OUT THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS, AND IT WAS NOTED THAT THERE WAS NO NEED FOR A FUTURE PROCEDURE AT THAT TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17619188 ↗

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

Other STENT, SUPERFICIAL FEMORAL ARTERY devices

All STENT, SUPERFICIAL FEMORAL ARTERY devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page