Innova™ Vascular H74939293061570Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729873686), received between Jul 17, 2018 and Jun 6, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2019Break; Premature Activation; Failure to Advance; Material Deformation; Break; Premature Activation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED AND UPON REMOVAL IT WAS CAUGHT ON THE Y CONNECTOR AND BECAME STRETCHED AND ULTIMATELY SEPARATED. THE 99% STENOSED, TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING PRE-DILATION, A 6 X 150 X 75 INNOVA STENT WAS ADVANCED IPSILATERAL OVER A .035 RADIOFOCUS STIFF GUIDEWIRE. WHEN THE DEVICE WAS ADVANCED TO THE SEVERELY CALCIFIED LESION THERE WAS SEVERE RESISTANCE FELT WITH THE DELIVERY SYSTEM. THE MIDDLE SHEATH GOT SHIFTED BACK AND THE TIP PART OF THE STENT BECAME SLIGHTLY DEPLOYED. DURING REMOVAL, THE STENT BECAME CAUGHT ON THE Y CONNECTOR, STRETCHED, AND SEPARATED. THE SYSTEM WAS REMOVED TOGETHER, AND THE ENTIRE STENT WAS ABLE TO BE RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 8675189 ↗
• MalfunctionJan 3, 2019Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE STENT BECAME STUCK ON THE GUIDEWIRE. AN INNOVA STENT WAS SELECTED FOR USE FOR A LOWER LIMB STENT PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS MODERATELY TORTUOUS, SEVERELY CALCIFIED AND 100% STENOSED. DURING PROCEDURE, THE STENT DELIVERY SYSTEM BECAME STUCK TO A NON-BSC GUIDEWIRE AND THE DELIVERY SHAFT BECAME STRETCHED. THE STENT WAS THEN REMOVED WITH THE GUIDEWIRE TOGETHER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INNOVA STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8214561 ↗
• InjuryJul 17, 2018Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 6 X 150 X 75 INNOVA¿ WAS IMPLANTED IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) IN (B)(6) 2018. THE PATIENT CAME BACK FOR A FOLLOW UP PROCEDURE IN (B)(6) 2018 DUE TO REOCCURRING SYMPTOMS. AT THIS TIME IT WAS NOTED THAT THE INNOVA STENT WAS FRACTURED AND SEPARATED IN TWO PLACES. THE FRACTURED STENT WAS STENTED ACROSS FOR REINFORCEMENT. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7694761 ↗

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