Innova™ Vascular H74939293068030Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729874010), received between Jun 7, 2017 and May 3, 2021 — classified as 1 injury, 4 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.

• MalfunctionMay 3, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED WHEN THE PACKAGING WAS OPENED. AN 6MM X 80MM X 130CM INNOVA VASCULAR SELF-EXPANDING STENT WAS CHOSEN FOR A SUPERFICIAL FEMORAL ARTERY (SFA) ANGIOPLASTY AND STENT PLACEMENT, TO TREAT PERIPHERAL ARTERY DISEASE. DURING PREPARATION, THE PACKAGING WAS OPENED AND THE STENT WAS PARTIALLY DEPLOYED. THE DEVICE WAS DISPOSED OF AND ANOTHER INNOVA WAS USED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761330 ↗
• MalfunctionOct 7, 2019Difficult to Insert; Premature Activation; Difficult to Insert; Premature Activation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. A 6X80X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR USE FOR A CHRONIC TOTAL OCCLUSION (CTO) OF THE SUPERFICIAL FEMORAL ARTERY (SFA) STENTING PROCEDURE. THE INNOVA DELIVERY SYSTEM WAS ADVANCED OVER A NON-BSC GUIDEWIRE INSIDE A NON-BSC SHEATH TO THE TARGET LESION. THERE WERE DIFFICULTIES ENCOUNTERED ENTERING THE SHEATH. THE PHYSICIAN REALIZED ON FLUORO THAT SOMETHING WAS NOT RIGHT BEFORE THE PHYSICIAN ATTEMPTED DEPLOY THE STENT. THE CATHETER AND STENT WERE REMOVED FROM THE PATIENT AND IT WAS NOTED STENT WAS PARTIALLY PREMATURELY DEPLOYED WITHOUT EXPANSION. THE PROCEDURE WAS COMPLETED WITH ANOTHER INNOVA STENT WITHOUT ANY ISSUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9162423 ↗
• MalfunctionSep 7, 2018Mechanical Problem; Failure to Advance; Mechanical Problem; Failure to Advance

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 6 X 80 X 130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR USE FOR A LOWER EXTREMITY ANGIO PROCEDURE. DURING PROCEDURE INSIDE THE PATIENT, THE INNOVA STENT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN DECIDED TO REMOVE THE STENT. AS THE STENT WAS REMOVED FROM THE 6F SHEATH, THE OUTER SHEATH OF THE STENT DELIVERY SYSTEM WAS ACCIDENTALLY RETRACTED AND THE STENT WAS EXPOSED. A NEW INNOVA STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7855164 ↗
• InjuryDec 22, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR 2134265-2017-13135 AND MDR 2134265-2017-13136. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2017, THE INDEX PROCEDURE WAS PERFORMED. THE PATIENT PRESENTED WITH CRITICAL ISCHEMIA, GANGRENE OF THE TOES AND RESTING PAIN THE RIGHT LEG. AN ANGIOGRAM OF THE RIGHT POPLITEAL ARTERY SHOWED THAT IT WAS OCCLUDED. AN ANGIOGRAM OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) SHOWED IT WAS OCCLUDED. A 5X150 INNOVA¿ STENT WAS PLACED IN THE RIGHT POPLITEAL ARTERY. THE STENT WAS POST-DILATED WITH A NON-BSC BALLOON. PRE-TREATMENT STENOSIS WAS 50% AND POST-TREATMENT STENOSIS WAS 0%. A 5X150 INNOVA¿ STENT WAS PLACED IN THE DISTAL RIGHT SFA. THE STENT WAS POST-DILATED WITH A NON-BSC BALLOON. PRE-TREATMENT STENOSIS WAS 50% AND POST-TREATMENT WAS 0%. A 6X80 INNOVA¿ STENT WAS PLACED IN THE PROXIMAL RIGHT SFA. THE STENT WAS POST-DILATED WITH A NON-BSC BALLOON. PRE-TREATMENT STENOSIS WAS 50% AND POST-TREATMENT WAS 0%. THE PROCEDURE HAD EXCELLENT RESULTS WITH PALPABLE PULSES POST INTERVENTION. THE PATIENT CONDITION WAS STABLE. ON (B)(6) 2017, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS IN BOTH 5X150 INNOVA¿ STENTS AND THE 6X80 INNOVA¿ STENT. AN ANGIOGRAM SHOWED THE RIGHT SFA

  Patient problems: Reocclusion

  MAUDE report 7142761 ↗
• MalfunctionJun 7, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. DURING PREPARATION FOR A STENTING PROCEDURE, THE PHYSICIAN SELECTED AN INNOVA 6 X 80 X 130 STENT. THE STENT DEPLOYED OUTSIDE THE PATIENT ON THE TABLE. THE DEVICE NEVER ENTERED THE PATIENTS BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6619501 ↗

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