Innova™ Vascular H74939293070230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729874072), received between Oct 4, 2018 and Dec 26, 2023 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2023Break; Premature Activation; Break; Premature Activation

  IT WAS REPORTED THAT SHAFT BREAK AND PREMATURE DEPLOYMENT OCCURRED. THE PATIENT WAS BEING TREATED FOR RENAL STENOSIS. AFTER PLACING A 6.5 NON-BOSTON SCIENTIFIC GUIDING SHEATH, A 7 X 20 X 130 INNOVA VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, THE DEVICE FRACTURED INSIDE THE PATIENT AND THE STENT PREMATURELY DEPLOYED IN THE SHEATH. THE STENT WAS SNARED, AND ANOTHER 7 X 20 X 130 INNOVA VASCULAR STENT WAS SUCCESSFULLY ADVANCED IN A LARGER SHEATH. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393299 ↗
• MalfunctionApr 9, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT AN INADVERTENT DEPLOYMENT OCCURRED. A 7X20X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR A STENTING PROCEDURE IN THE EXTERNAL ILIAC ARTERY. DURING PREPARATION, WHEN THEY PULLED THE DEVICE OUT OF THE PLASTIC COVER, IT STILL HAD THE SAFETY MECHANISM OVER THE THUMBWHEEL. THE FLUSH PORT WAS SILL ON THE BACK OF THE HANDLE. WHEN LOOKING AT THE STENT WHILE FLUSHING, IT WAS NOTED THAT HALF OF THE STENT WAS STICKING OUT THE END OF THE CATHETER. IT WAS PARTIALLY DEPLOYED OUT OF THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT INNOVA STENT (7X40). THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8496316 ↗
• MalfunctionOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14SEP2018. THE 7 X 20 X 130 INNOVA WAS RETURNED WITH NO KNOWN COMPLAINT. HOWEVER, DEVICE ANALYSIS FOUND THE DEVICE WAS STUCK ON THE GUIDEWIRE. DEVICE EVAL BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF AN INNOVA SELF-EXPANDING STENT DELIVERY SYSTEM (SDS). THE OUTER SHEATH, MIDDLE SHAFT, AND THE REMAINDER OF THE DEVICE WERE CHECKED FOR DAMAGE. THE DEVICE SHOWED THAT A GUIDEWIRE WAS STUCK IN THE DEVICE. THE MID-SHAFT WAS KINKED 23CM FROM THE DISTAL SIDE OF THE MARKERBAND. THERE WAS A KINK AND BUCKLING AT THE NOSECONE. THERE WAS BUCKLING 2CM FROM THE NOSECONE. THERE WAS A KINK ON THE INNER LINER LOCATED AT 10CM FROM THE TIP. THERE WAS NO STENT IN THE DEVICE WHEN RETURNED. THE GUIDEWIRE STICKING IS CONSISTENT WITH THE BUCKLING DAMAGE CONSTRICTING DOWN ON THE WIRE AND INHIBITING IT FROM EXITING THE CATHETER SHAFT. INSPECTION OF THE REMAINDER OF THE DEVICE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7935103 ↗

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