Innova™ Vascular H74939293051230Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729873945), received between Aug 14, 2018 and Jun 21, 2023 — 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.

• MalfunctionJun 21, 2023Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. THIS 5 X 120 X 130 INNOVA VASCULAR STENT WAS SELECTED FOR USE IN A DISTAL SUPERFICIAL FEMORAL ARTERY STENTING PROCEDURE. DURING PREPARATION, UPON OPENING THE PACKAGING IT WAS NOTED THAT THE SHEATH COVERING THE STENT WAS PARTIALLY PULLED BACK FROM THE STENT; THEREBY INADVERTENTLY DEPLOYING THE STENT. THE YELLOW PROTECTIVE SAFETY CLIP REMAINED IN PLACE AND THE THUMBWHEEL WAS NOT TOUCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170238 ↗
• MalfunctionOct 4, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. THE TARGET LESION WAS 99% STENOSED, SEVERELY CALCIFIED WITH PLAQUE AND LOCATED IN THE MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). VASCULAR ACCESS WAS OBTAINED VIA AN IPSILATERAL PEDAL APPROACH FROM THE POSTERIOR TIBIAL ARTERY. PRE-DILATION WAS PERFORMED WITH A 5X150 STERLING BALLOON CATHETER. DURING ADVANCEMENT OF THE INNOVA STENT DELIVERY SYSTEM THROUGH THE LESION, THE STENT PREMATURELY DEPLOYED BY APPROXIMATELY 5 TO 10MM. THE STENT AND SHEATH WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE IMPLANT OF A NEW DEVICE. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569630 ↗
• InjurySep 4, 2019Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT STENT ELONGATION OCCURRED RESULTING IN PATIENT SURGERY. AN INNOVA (5X120X130CM) SELF EXPANDING STENT WAS SELECTED FOR TREATMENT IN A LOWER EXTREMITY PERIPHERAL ANGIOGRAM PROCEDURE. THE INNOVA STENT WAS PLACED IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT ANY NOTED RESISTANCE DURING DEPLOYMENT. THE PHYSICIAN USED THE PULL GRIP TO COMPLETE THE DEPLOYMENT PROCESS AND STARTED TO RETRACT THE STENT DELIVERY SYSTEM BACK ON THE 0.035 GUIDEWIRE AND THROUGH THE 6F NON-BSC SHEATH. THE INNOVA STENT WAS OBSERVED TO BE STRETCHED WHEN THE DEVICE WAS RETRACTED THROUGH THE 6F NON-BSC SHEATH WHICH WAS LOCATED IN THE IN THE LEFT COMMON FEMORAL ARTERY (CFA) EXTENDING INTO THE PROXIMAL RIGHT SFA. THE STENT DELIVERY SYSTEM WAS FULLY REMOVED FROM THAT PATIENT. THE 0.035 GUIDEWIRE REMAINED IN PLACE THROUGH THE ENTIRE RIGHT SFA. IT APPEARED THAT 40MM OF THE STENT WAS DEPLOYED NORMALLY IN THE DISTAL SFA BEFORE THE STENT BEGAN TO STRETCH BACK ENDING WITH THE PROXIMAL END OF THE STENT BEING 80MM IN THE SHEATH. THE PHYSICIAN ESTIMATED THAT THE STENT STRETCHED ABOUT 300MM ITS ENTIRETY. THE PHYSICIAN WAS NOT ABLE TO GET THE STENT OUT OF THE SHEATH. THE PATIENT WAS IN STABLE CO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962221 ↗
• MalfunctionJul 15, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DELIVERY SYSTEM BECAME STUCK ON THE WIRE. A 5X120X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR A PERIPHERAL INTERVENTION. THE LESION WAS 80% STENOSED, THE DEGREE OF TORTUOSITY FOR THIS CASE WAS MINIMAL, AND THERE WAS NO CALCIFICATION. THE LESION WAS PRE-DILATED AND USING A CONTRALATERAL APPROACH OVER A .014 THRUWAY GUIDEWIRE, THE STENT WAS DEPLOYED. DURING REMOVAL OF THE DELIVERY SYSTEM, IT BECAME STUCK ON THE WIRE. EVERYTHING WAS REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED BY USING A BALLOON FOR POST DILATATION OF THE STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8789800 ↗
• 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 7783224 ↗

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