Innova™ Vascular H74939293071030Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729874119), received between Oct 30, 2017 and Jul 28, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060365 ↗
• MalfunctionApr 10, 2020Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. A 7X100X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR A PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN TRIED TO ADVANCE THE STENT THROUGH THE SHEATH IN A PEDAL APPROACH TO THE SFA. WHEN ATTEMPTED TO PUSH THROUGH THE ANATOMY, IT WOULD NOT ADVANCE. THE STENT WAS PULLED BACK AND THE STENT DEPLOYED IN THE SHEATH. THE SHEATH AND STENT WERE BOTH REMOVED FROM THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING A NEW SHEATH AND A BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9948364 ↗
• MalfunctionFeb 18, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT AN INADVERTENT DEPLOYMENT OCCURRED. A 7X100X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR AN ANGIOPLASTY PROCEDURE IN A LESION WITH MINIMAL CALCIFICATION, MOSTLY ATHEROSCLEROTIC PLAQUE, 80% STENOSED AND MINIMAL TORTUOSITY VIA CONTRALATERAL APPROACH. DURING PREPARATION, AFTER FLUSHING THE STENT, IT WAS DISCOVERED THAT THE STENT HAD ALREADY DEPLOYED APPROXIMATELY 1-2MM FROM THE DISTAL END OF THE STENT. THE DEVICE DID NOT ENTER THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SHORTER STENT TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9719957 ↗
• MalfunctionSep 6, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE STENT BECAME STUCK ON THE GUIDEWIRE. A 7X100X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR USE FOR A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTIONAL PROCEDURE. THE STENT WAS ATTEMPTED TO DEPLOY, HOWEVER, IT BECAME STUCK ON A MAGIC TORQUE GUIDEWIRE. THE PHYSICIAN THEN REMOVED THE STENT AND DELIVERY SYSTEM, ALONG WITH THE WIRE OUT OF THE PATIENT THROUGH THE SHEATH. THE PHYSICIAN HAD TO REGAIN WIRE ACCESS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS POST PROCEDURE WAS STABLE. THE OUTER SHAFT, MIDDLE SHAFT AND THE REMAINDER OF THE DEVICE WERE CHECKED FOR DAMAGE. THERE WAS A KINK AT THE NOSECONE. NO WIRE WAS IN THE DEVICE WHEN RETURNED. A .035 AMPLATZ TEST GUIDEWIRE WAS INSERTED INTO THE DEVICE AND THE WIRE TRANSCENDED THROUGH THE DEVICE WITH NO HESITATIONS OR RESTRICTIONS UNTIL THE KINK AT THE NOSE CONE WHERE A RESTRICTION WAS FELT. WITH APPLIED PRESSURE THE WIRE TRANSCENDED THROUGH THE REST OF THE DEVICE. THE STENT WAS NOT RETURNED. 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 7852181 ↗
• MalfunctionOct 30, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT DEPLOYED INADVERTENTLY. A 7 X 100 X 130 INNOVA¿ WAS SELECTED FOR A PROCEDURE. DURING PREPARATION, WHILE INJECTING SALINE IN THE YELLOW FLUSH PORT, THE STENT CAME OUT OF THE SHEATH. THE STENT WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6988874 ↗

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