Innova™ Vascular H74939293064070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729873631), received between Nov 16, 2016 and Jun 9, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• InjuryJun 9, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE STENT JUMPED. A 6MM X 40MM X 75CM INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE IN A LEFT UPPER EXTREMITY FISTULAGRAM WITH ANGIOPLASTY AND STENTING. THERE WAS TIGHT STENOSIS IN THE DISTAL PORTION OF THE LEFT UPPER EXTREMITY FISTULA, WHICH WAS PRE-DILATED WITH A 6MM X 40MM GLADIATOR BALLOON. THE PHYSICIAN WAS IN THE PROCESS OF DEPLOYING THE INNOVA STENT, BUT THE STENT RELEASED AND MIGRATED TO THE AUXILIARY VEIN BEFORE FINISHING DEPLOYMENT. A 7MM X 40MM GLADIATOR BALLOON WAS USED TO PULL THE STENT BACK DOWN TOWARDS THE LESION. IT STOPPED PROXIMAL TO THE LESION. A 7MM X 40MM INNOVA STENT WAS THEN USED TO BOTH COVER THE STENOTIC LESION AND SECURE THE PREVIOUSLY DEPLOYED 6MM X 40MM INNOVA STENT IN PLACE JUST ABOVE THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101392 ↗
• MalfunctionApr 26, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT OCCURRED. THE 99% STENOSED, FOCAL TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). AFTER PASSING THROUGH THE 6F SHEATH, PRE-DILATION WAS PERFORMED AND A 6 X 40 X 75 INNOVA¿ STENT WAS ADVANCED IPSILATERAL FEMORAL APPROACH OVER THE .014 GUIDEWIRE AND STENT DEPLOYMENT WAS INITIATED. SEVERE RESISTANCE WAS FELT WHEN THE THUMBWHEEL WAS TURNED AND THE STENT WAS ONLY SLIGHTLY DEPLOYED. THE PHYSICIAN ATTEMPT TO DEPLOY ANY FURTHER AND STENT PLACEMENT WAS STOPPED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS POST PROCEDURE WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7466740 ↗
• InjuryFeb 16, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE TARGET LESION WAS 99% STENOSED, MILDLY CALCIFIED AND MILDLY TORTUROUS SHUNT. A 6 X 40 X 75MM INNOVA¿ STENT WAS ADVANCED. THE PHYSICIAN STRETCHED AND PULLED THE STENT DURING DEPLOYMENT AND THE STENT BECAME SHORTENED; THE PHYSICIAN INDICATED IT WAS NOT 4 CM IN LENGTH. THE SHORTENED STENT REMAINED IMPLANTED AND WAS WELL APPOSED TO THE VESSEL WALL, BUT DID NOT COVER THE ENTIRE LESION. A 6 X 60MM INNOVA¿ STENT WAS PLACED FURTHER IN THE INITIAL STENT, TO COVER THE REMAINDER OF THE LESION. THERE WERE NO FURTHER PATIENT COMPLICATIONS. THE PATIENT¿S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6335432 ↗
• MalfunctionNov 16, 2016Premature Activation; Device Damaged Prior to Use; Premature Activation; Device Damaged Prior to Use

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. A 6X40X75 INNOVA STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION OF THE STENT, IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS PARTIALLY DEPLOYED. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6108342 ↗

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