Innova™ Vascular H74939293066030Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729874003), received between Mar 1, 2017 and Oct 27, 2025 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY. A 6 X 60 X 130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, THE STENT STARTED TO DEPLOY WHILE BEING LOADED ONTO THE WIRE, BEFORE ENTERING THE PATIENT'S BODY. THE YELLOW SAFETY MECHANISM WAS STILL IN PLACE. THE STENT DID NOT ENTER THE PATIENT'S BODY AND WAS REMOVED FROM THE WIRE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23395153 ↗
• MalfunctionFeb 20, 2024Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT DEVICE ENTRAPMENT AND PREMATURE DEPLOYMENT OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENTING OF THE 90% STENOSED TARGET LESION LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH. A 6F 45CM CATAPULT GUIDE SHEATH WAS ADVANCED WITH DIFFICULTY OVER THE ILIAC BIFURCATION FOLLOWED BY CROSSING A 035 NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE INTO THE LESION. PRE-DILATATION WAS PERFORMED WITH A 5 X 220 STERLING BALLOON CATHETER WITH 60% RESIDUAL STENOSIS. A 6 X 60 X 130 INNOVA VASCULAR STENT WAS ADVANCED FOR TREATMENT. IT WAS NOTED THAT THE GUIDEWIRE WAS FLUSHED WITH HEPARINIZED SALINE. HOWEVER, DURING INSERTION, THE STENT GOT STUCK ON THE GUIDEWIRE AND STARTED TO DEPLOY OUTSIDE THE PATIENT BEFORE EVER GETTING INTO THE SHEATH. THE STENT AND THE GUIDEWIRE HAD TO BE REMOVED TOGETHER DUE TO THE WIRE BEING STUCK IN THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A STIFF ZIPWIRE AND A 6 X 80 INNOVA VASCULAR STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743853 ↗
• InjuryApr 19, 2022Fracture; Device-Device Incompatibility; Fracture; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STENT FRACTURED. A 6X60X130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR USE. THE TARGET LESION WAS LOCATED IN THE COMMON FEMORAL ARTERY. THE STENT WAS SUCCESSFULLY PLACED. A NON-BSC DEVICE WAS USED TO CLOSE THE VASCULAR ACCESS SITE. WHEN IT WAS PLACED, IT PUSHED ON THE STENT AND CAUSED THE STENT TO FRACTURE. THE PATIENT HAD TO BE REPUNCTURED, AND AN ADDITIONAL INNOVA STENT WAS SUCCESSFULLY PLACED WITHIN THE ORIGINAL STENT TO MAKE IT DURABLE IN THE VESSEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14153662 ↗
• MalfunctionJun 1, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED INSIDE OF THE PACKAGING. A 6 X 60 X 130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR A PATIENT PROCEDURE. DURING PREPARATION, THE STENT WAS NOTED TO BE PARTIALLY DEPLOYED UPON REMOVAL FROM BOX; A FEW TINES WERE SHOWING. THE DEVICE WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11914119 ↗
• MalfunctionSep 4, 2020Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO TRACK OVER THE WIRE AND INADVERTENTLY DEPLOYED. A 6X60X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR A PROCEDURE. UPON INSERTING THE STENT DELIVERY SYSTEM OVER THE .014 WIRE, IT WAS DIFFICULT TO TRACK. PRIOR TO ENTERING THE SHEATH, THE PHYSICIAN NOTICED THE STENT HAD FLOWERED OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW 6X60 INNOVA DEVICE AND PATIENT WAS REPORTED AS FINE POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10493891 ↗
• MalfunctionOct 15, 2019Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE STENT WAS DAMAGED. A 6 X 60 X 130 CM INNOVA SELF-EXPANDING STENT WAS SELECTED TO BE IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE STENT WAS DAMAGED AND WOULD NOT DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT, AND A NEW INNOVA DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9191467 ↗
• MalfunctionNov 29, 2018Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED WHEN ATTEMPTING TO REMOVE IT FROM BEING STUCK TO THE WIRE. A 6X60X130 INNOVA VASCULAR STENT WAS SELECTED FOR USE FOR A STENTING PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING PREPARATION, OUTSIDE OF THE PATIENT'S BODY, THE PHYSICIAN ATTEMPTED TO LOAD THE STENT OVER AN UNSPECIFIED .035 GUIDEWIRE BUT THE STENT BECAME STUCK ON THE GUIDEWIRE. WHEN THE PHYSICIAN ATTEMPTED TO PULL THE STENT OFF OF THE WIRE, THE STENT STARTED TO INADVERTENTLY DEPLOY. IT PARTIALLY DEPLOYED. ANOTHER INNOVA VASCULAR STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. DEVICE EVALUATED BY MFR: THE OUTER SHEATH, TIP, INNER SHEATH AND THE REMAINDER OF THE DEVICE WERE CHECKED FOR DAMAGE. VISUAL EXAMINATION REVEALED A KINK AT THE NOSECONE. KINKS AT THE NOSECONE MOST LIKELY OCCURS FROM HANDLING, WHEN IT IS PACKAGED TO BE RETURNED FOR INVESTIGATION. THE YELLOW THUMBWHEEL PROTECTOR IS STILL ATTACHED BUT IS ON BACKWARDS. THE PULL GRIP IS PULLED 33MM OUT AND THERE IS BLOOD PRESENT IN THE INNER LINER. THE STENT WAS COMPLETELY OUTSIDE OF THE DEVICE. MICROSCOPIC EXAMINATION REVEALED THAT THERE IS FOREIGN MATERIAL (FM) PRES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117874 ↗
• InjuryNov 13, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE STENT MOVED DURING DEPLOYMENT. A 6X60X130MM INNOVA VASCULAR STENT WAS SELECTED FOR USE FOR A PERIPHERAL STENTING PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN WENT TO DEPLOY THE STENT, AND THE STENT MOVED ABOUT 3MM DURING DEPLOYMENT. THERE WERE NO DEPLOYMENT DIFFICULTIES NOTED. THE PHYSICIAN NEEDED TO USE A SECOND, LARGER INNOVA STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION POST PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8066378 ↗
• MalfunctionSep 10, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT DEPLOYED INADVERTENTLY UPON ADVANCING IT OVER A WIRE. A 6X60X130 INNOVA VASCULAR STENT WAS SELECTED FOR USE DURING A PROCEDURE LOCATED IN THE PATIENT'S LEFT SUPERFICIAL FEMORAL ARTERY (SFA). WHILE PHYSICIAN WAS ADVANCING OVER A ROSEN WIRE, APPROXIMATELY 1/3 OF THE STENT PARTIALLY DEPLOYED. THIS OCCURRED OUTSIDE OF THE PATIENT'S BODY. THE CAUSE OF THIS ISSUE IS BELIEVED TO BE RELATED TO THE DEVICE STICKING TO THE WIRE. THE STENT AND WIRE WERE REMOVED AND REPLACED WITH ANOTHER WIRE AND INNOVA. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7862210 ↗
• InjuryMar 14, 2018Fracture; Fracture

  IT WAS REPORTED THAT THROMBOSIS AND A STENT FRACTURE OCCURRED. A 6X60X130 INNOVA¿ STENT WAS SELECTED FOR A PROCEDURE ON (B)(6) 2017. ON (B)(6) 2018, THE PATIENT PRESENTED WITH LEFT LEG CLAUDICATION. THROMBOSIS WAS OBSERVED IN THE PREVIOUSLY PLACED STENT IN THE LEFT LEG. IT WAS NOTED THAT THE STENT WAS FRACTURED. THE PATIENT WAS TREATED WITH ANGIOPLASTY, ARTHRECTOMY AND A NEW INNOVA STENT WAS PLACED INSIDE THE CURRENT INNOVA STENT. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION POST PROCEDURE WAS STABLE.

  Patient problems: Claudication; Thrombosis

  MAUDE report 7338978 ↗
• InjuryNov 17, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR 2134265-2017-11106 AND MDR 2134265-2017-11105. IT WAS REPORTED THAT IN STENT RESTENOSIS OCCURRED. ON (B)(6) 2016 THE PATIENT PRESENTED WITH ATHEROSCLEROSIS OF NATIVE ARTERIES OF EXTREMITIES WITH REST PAIN IN THE LEFT LEG AND THE INDEX PROCEDURE WAS PERFORMED. AN ANGIOGRAM OF THE LEFT COMMON FEMORAL ARTERY FOUND THAT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND LEFT POPLITEAL ARTERY WERE OCCLUDED. FOLLOWING PRE-DILATION, A 6X150 INNOVA STENT WAS PLACED SUCCESSFULLY IN THE LEFT POPLITEAL ARTERY, FOLLOWED BY POST-DILATION. PRE-TREATMENT STENOSIS WAS 50%, POST-TREATMENT STENOSIS WAS 0%. FOLLOWING PRE-DILATION, A 6X150 INNOVA STENT WAS PLACED SUCCESSFULLY IN THE DISTAL LEFT SFA, FOLLOWED BY POST-DILATION. PRE-TREATMENT STENOSIS WAS 50%, POST-TREATMENT STENOSIS WAS 50%. FOLLOWING PRE-DILATION, A 6X120 INNOVA STENT WAS PLACED SUCCESSFULLY IN THE PROXIMAL LEFT SFA, FOLLOWED BY POST-DILATION. PRE-TREATMENT STENOSIS WAS 50%, POST-TREATMENT STENOSIS WAS 0%. THERE WERE EXCELLENT RESULTS IN THE THREE VESSEL RUNOFF AND IMPROVED DOPPLERS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S CONDITION POST PROCEDURE WAS STABLE. ON (B)(6) 2017 THE PATIENT PRESENTED WITH

  Patient problems: Reocclusion

  MAUDE report 7042970 ↗
• MalfunctionMar 1, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DEPLOYMENT ISSUES OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6 X 60 X 130 INNOVA¿ STENT WAS ADVANCED AND THE DISTAL END OPENED, HOWEVER, THE PROXIMAL END DID NOT OPEN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370502 ↗

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