Innova™ Vascular H74939293061870Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729873693), received between Nov 22, 2016 and Jul 12, 2017 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2017Stretched; Stretched

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). IPSILATERAL ANTEGRADE APPROACH WAS PERFORMED. FOLLOWING PRE-DILATION, A 6X180X75 INNOVA STENT WAS PLACED AND DEPLOYMENT WAS INITIATED VIA THE THUMB WHEEL. DURING DEPLOYMENT THE STENT STRETCHED ABOUT 2CM ON THE PROXIMAL SIDE. THE PHYSICIAN STATES THAT HE FELT TENSION ON THE SHAFT AT THE TIME OF THE EVENT. AFTER DEPLOYING 120MM OF THE STENT, THE DEPLOYMENT STOPPED, THE PHYSICIAN CONTINUED TO TURN THE THUMBWHEEL AND DEPLOYMENT WAS EVENTUALLY ACHIEVED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6709032 ↗
• MalfunctionNov 22, 2016Bent; Activation, Positioning or Separation Problem; Bent; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THERE WAS PARTIAL DEPLOYMENT AND STENT DAMAGE. A 6 X 180 X 75 INNOVA¿ SELF-EXPANDING STENT WAS SELECTED FOR AN EVT PROCEDURE IN THE MILDLY TORTUOUS 100% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA). AN IPSILATERAL ANTEGRADE APPROACH WAS USED TO ACCESS THE LESION. THE LESION WAS 2 MM PRE-DILATED. THE INNOVA WAS INSERTED BY A NON-BSC GUIDEWIRE, BUT IT WAS NOT ABLE TO CROSS THE LESION. IT WAS ABLE TO CROSS THE LESION AFTER THE GUIDEWIRE WAS CHANGED TO A 0.35. THE STENT WAS DEPLOYED BY THE THUMB WHEEL UP TO 12 CM WITHOUT ANY RESISTANCE. AFTER THAT, IT WAS NOT ABLE TO PERFORM PULL BACK AND DEPLOY COMPLETELY. THE THUMBWHEEL WAS USED WITH NORMAL FORCE UNTIL THE WHITE ARROW WAS VISIBLE. THE PULL GRIP WAS NOT USED. THE HANDLE WAS DISASSEMBLED AND IT WAS FOUND THAT THE STENT WAS STRETCHED AND DEPLOYED IN THE SHEATH. THE STENT WAS ABLE TO BE PUSHED INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE STENT DID NOT FRACTURE AND THERE WERE NO KINKS. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6120195 ↗

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