Innova™ Vascular H74939293071570Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729873778), received between Dec 5, 2018 and Dec 5, 2018 — 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

Recent adverse event reports

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

• MalfunctionDec 5, 2018Positioning Failure; Activation, Positioning or Separation Problem; Material Deformation; Positioning Failure; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT AND STENT DAMAGE OCCURRED. THE 100% STENOSED, FOCAL TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING PRE-DILATATION, A 6MM X15CM INNOVA STENT WAS ADVANCED OVER A .014 WIRE AND DEPLOYED IN THE DISTAL SFA SUCCESSFULLY. A 7MM X 15CM INNOVA STENT WAS THEN ADVANCED IPSILATERAL AND STENT DEPLOYMENT WAS INITIATED. THE THUMBWHEEL SUDDENLY STOPPED MOVING AFTER THE STENT WAS DEPLOYED APPROXIMATELY HALF TO TWO THIRDS. THE PULL GRIP WAS ATTEMPTED TO DEPLOY THE REMAINDER OF THE STENT BUT THIS WAS UNSUCCESSFUL. THE SHEATH WAS PUSHED AND WHILE THE STENT SYSTEM WAS PUSHED AND PULLED REPEATEDLY AT THE SAME TIME, THE STENT WAS ABLE TO DEPLOY LITTLE BY LITTLE UNTIL THE STENT WAS ABLE TO FULLY DEPLOY. THE PLACED STENT WAS PARTIALLY STRETCHED AND THERE WERE MANY AREAS NOT SUFFICIENTLY DILATED. A NEW WIRE AND A NEW BALLOON WERE USED TO DILATE THE AREAS WITH INSUFFICIENT DILATATION. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8135398 ↗

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