Innova™ Vascular H74939293078030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729874102), received between Nov 10, 2017 and Sep 3, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. A 7 X 80 X 130 INNOVA STENT WAS SELECTED FOR THE SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION. HOWEVER, IT WAS NOTED THAT THE STENT SYSTEM WAS INTACT WHEN IT WAS UNPACKED, BUT FEW STRUTS WERE VISIBLE ON THE STENT. THE DEVICE WAS NOT USED FOR THIS PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20124951 ↗
• MalfunctionJan 9, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. THE PROCEDURE WAS PERFORMED VIA CONTRALATERAL APPROACH. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AFTER CROSSING THE LESION WITH A 035 ZIPWIRE GUIDEWIRE, PRE-DILATATION WAS PERFORMED. A 7 X 80 X 130 INNOVA VASCULAR STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS FOUND THAT 20% OF THE STENT HAD ALREADY DEPLOYED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 7 X 60 X 130 INNOVA VASCULAR STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477699 ↗
• MalfunctionSep 6, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE STENT WAS SHORTER THAN THE LABELED SIZE. TWO 7X80X130 INNOVA SELF EXPANDING STENTS WERE SELECTED FOR USE FOR A STENTING PROCEDURE IN THE RIGHT ILIAC ARTERY. THE FIRST STENT WAS DEPLOYED SUCCESSFULLY AND HAD A LENGTH OF 80MM. THE SECOND STENT WAS ALSO DEPLOYED SUCCESSFULLY. BALLOON ANGIOPLASTY WAS DONE AFTER BOTH STENTS WERE DEPLOYED. UPON RADIOGRAPHIC IMAGING, IT APPEARED THAT THE SECOND STENT WAS SIGNIFICANTLY SHORTER, AROUND 60MM FULLY DEPLOYED. THE STENT STILL COVERED THE ENTIRE LESION. THE CASE WAS COMPLETED WITH THE SAME DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED. DEVICE EVALUATED BY MFR: THE OUTER SHAFT, MIDDLE SHAFT, INNER SHEATH AND THE REMAINDER OF THE DEVICE WERE CHECKED FOR DAMAGE. THE OUTER SHEATH WAS KINKED AT THE NOSECONE. THE INNER LINER SHOWED A KINK AT 9.5CM FROM THE TIP. THE STENT WAS NOT RETURNED; THEREFORE, THE LENGTH OF THE STENT COULD NOT BE MEASURED. 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 7852154 ↗
• InjuryNov 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MR ID# 2134265-2017-10895, 2134265-2017-10894, 2134265-2017-10897, 2134265-2017-10898. IT WAS REPORTED THAT A PERFORATION OCCURRED. THE PATIENT PRESENTED VERY ILL. THE PATIENT WAS BEING TREATED FOR BI-LATERAL ILIAC ARTERY RECANALIZATION. VASCULAR ACCESS WAS GAINED VIA THE RIGHT POPLITEAL ARTERY WITH A 6F SHEATH. THE ILIAC ARTERY WAS THEN CROSSED WITH A NON BSC GUIDEWIRE AND A SUPPORT CATHETER. PRE-DILATION WAS PERFORMED USING A 4X60MM MUSTANG BALLOON CATHETER. AN EXPRESS LD 6X40 STENT WAS IMPLANTED ALONG WITH TWO INNOVA STENTS (7X60MM AND 7X80MM) IN BOTH THE RIGHT EXTERNAL ILIAC ARTERY AND THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN THEN WENT TO TAKE IMAGES AND NOTICED BLEEDING IN THE RIGHT EXTERNAL ILIAC ARTERY AND SUSPECTED A PERFORATION. THE PERFORATION WAS TREATED WITH 2 NON BSC COVERED STENTS ALONG WITH MULTIPLE PROLONGED ANGIOPLASTY BALLOON INFLATIONS TO CONTROL THE BLEED. ONCE THE BLEEDING WAS CONTROLLED, THE PHYSICIAN WENT TO REMOVE THE SHEATH FROM THE POPLITEAL ARTERY WHEN CLOTTING WAS THEN OBSERVED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN TRIED TO ASPIRATE THE CLOT THROUGH THE SHEATH, AND THEN BY USING A GUIDE CATHETER, WITHOUT SUCCESS. M

  Patient problems: Perforation of Vessels

  MAUDE report 7023025 ↗

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