Innova™ Vascular H74939293051030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729873938), received between Aug 14, 2018 and Dec 21, 2023 — classified as 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A 5 X 100 X 130 INNOVA VASCULAR SELF-EXPANDING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373750 ↗
• MalfunctionFeb 11, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. A 5MM X 100MM X 130CM INNOVA WAS SELECTED FOR USE IN A STENTING PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE STENT BEGAN TO DEPLOY BEFORE IT WAS IN POSITION. THE DEPLOYMENT SAFETY TOOL WAS STILL ON. THE DEVICE WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 5MM X 100MM INNOVA. NO PATIENT COMPLICATIONS WERE REPORTED, AND IT WAS A GOOD OUTCOME. IT WAS FURTHER REPORTED THAT: A CONTRALATERAL APPROACH WAS TAKEN TO ACCESS THE LESION AND THE SAFETY LOCK WAS STILL IN PLACE PRIOR TO POSITIONING IN THE LESION. EXPOSING THE STENT PRIOR TO DEPLOYMENT WAS PERFORMED AS DIRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317213 ↗
• MalfunctionDec 11, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED. A 5X100X130MM INNOVA VASCULAR STENT WAS SELECTED FOR USE FOR A SUBCLAVIAN GRAFT BYPASS PROCEDURE IN THE LEG. THE TARGET LESION DID NOT HAVE MUCH TORTUOSITY, HAD NO CALCIFICATION, AND NO STENOSIS WAS OBSERVED, HOWEVER, THE TARGET LESION WAS THROMBOSED. FOLLOWING PRE-DILATION, THE INNOVA STENT WAS ADVANCED OVER A .018 GUIDEWIRE AND DEPLOYMENT INITIATED. THE STENT ONLY BEGAN TO FLOWER FROM THE DEPLOYMENT SYSTEM WHEN THE THUMBWHEEL BEGAN TO SPIN FREELY WITHOUT THE STENT DEPLOYING ANY FURTHER. THE PULL GRIP WAS THEN ATTEMPTED AND AGAIN THE STENT DID NOT DEPLOY. THE PHYSICIAN ALSO ATTEMPTED TO BREAK OPEN THE HANDLE TO SEE IF THE STENT COULD BE DEPLOYED, BUT THIS WAS UNSUCCESSFUL. THE PHYSICIAN ALSO ATTEMPTED TO SWITCH OUT THE GUIDEWIRE FOR A .035 SIZE AND THAT WAS ALSO UNSUCCESSFUL. THE PHYSICIAN THEN INSERTED A LARGER AND LONGER SHEATH AND WAS ABLE TO WITHDRAW THE STENT INTO THE SHEATH AND REMOVE THE STENT AND DELIVERY SYSTEM TOGETHER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS POST PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8152384 ↗
• MalfunctionAug 14, 2018Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THE DELIVERY SYSTEM BECAME STUCK ON THE GUIDEWIRE. VASCULAR ACCESS WAS OBTAINED VIA RAIL ACCESS IN THE GROIN AND POPLITEAL. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A .035 ZIPWIRE WAS PUT INTO POSITION AND THEN A 5 X 120 X 130 INNOVA AND A 5 X 100 X 130 INNOVA WERE LOADED OVER BOTH ENDS OF THE WIRE AND ADVANCED TO THE TREATMENT SITE. THE STENT DELIVERY SYSTEMS BECAME STUCK ON THE ZIPWIRE DURING ADVANCEMENT TO THE TARGET LESION. WHILE TRYING TO REMOVE ONE OF THE DELIVERY SYSTEMS, THE STENT BEGAN TO DEPLOY. THE PHYSICIAN PUSHED THE ZIPWIRE OUT OF THE PATIENT ENOUGH THAT ONE OF THE STENTS WAS OUTSIDE THE PATIENT AND THE PHYSICIAN WAS ABLE TO CUT THE WIRE. THE REST OF THE WIRE AND THE SECOND INNOVA STENT WAS ABLE TO BE REMOVED FROM THE PATIENT WITH NO FURTHER COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICES. THE PATIENT WAS FINE POST PROCEDURE. RETURNED PRODUCT CONSISTED OF AN INNOVA SELF-EXPANDING STENT DELIVERY SYSTEM (SDS). VISUAL EXAMINATION SHOWED A KINK AT THE NOSECONE. NO DAMAGE WAS NOTICED ON THE MID-SHAFT. THE YELLOW THUMBWHEEL LOCK WAS INTACT ON THE DEVICE AND THE PULL HANDLE WAS IN THE START POSITION. THE STENT W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7783202 ↗

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