Innova™ Vascular H74939293060230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729873983), received between Oct 17, 2018 and Oct 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2023Difficult to Insert; Premature Activation; Difficult to Insert; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 6 X 20 X 130 INNOVA VASCULAR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS NOT FITTING THROUGH THE APPROPRIATELY SIZED SHEATH. THE STENT SELF DEPLOYED OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER INNOVA STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886173 ↗
• MalfunctionOct 17, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED STENT PLACEMENT DIFFICULTIES OCCURRED. A STENTING PROCEDURE WAS BEING PERFORMED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIUM USING A RETROGRADE POPLITEAL APPROACH. AS THE INNOVA 6 X 20 X 130 STENT WAS POSITIONED AND DEPLOYMENT INITIATED, THE STENT MOVED FORWARD AND PARTIALLY COVERED THE PROFUNDA ARTERY. IT WAS NOTED THE PHYSICIAN THOUGHT THE DEVICE WAS BEING HELD STEADY IN POSITION AND WAS SURPRISED THAT THE STENT MOVED FORWARD. THE STENT WAS POST DILATED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT OUTCOME. IT WAS NOTED THERE WAS NO NEED TO DO ANYTHING FURTHER, THE PHYSICIAN JUST DIDN'T LIKE THE FINAL POSITION OF THE STENT. DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF AN INNOVA SELF-EXPANDING STENT DELIVERY SYSTEM (SDS). A VISUAL EXAMINATION IDENTIFIED A KINK AT THE NOSECONE. THE STENT WAS NOT RETURNED. PER THE CUSTOMERS STATEMENT THE STENT WAS DEPLOYED IN THE PATIENT. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7976124 ↗

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