Innova™ Vascular H74939293061030Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729874027), received between Mar 16, 2017 and Apr 15, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem; Packaging Problem

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6 X 100 X 130 INNOVA STENT SELF EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN INNOVA WAS ADVANCED OVER THE WIRE WITH THE YELLOW SAFETY LOCK IN PLACE, IT WAS NOTED THAT 5 MILLIMETERS (MM) OF THE STENT WAS DEPLOYED, AND THAT THE PARTIAL DEPLOYMENT OCCURRED OUTSIDE THE PATIENT. IT WAS ALSO REPORTED THAT THE PACKAGE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885645 ↗
• MalfunctionOct 23, 2023Fracture; Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Advance; Fracture; Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Advance

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND THEN FRACTURED UPON REMOVAL.. THIS 6 X 100 X 130 INNOVA VASCULAR STENT WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE 90% STENOSED, MODERATELY TORTUOUS, MODERATELY CALCIFIED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE STENT WAS DIFFICULT TO ADVANCE TO THE LESION. ONCE AT THE LESION, THE STENT WOULD NOT DEPLOY AS THE PHYSICIAN ROLLED THE DELIVERY THUMB WHEEL. THEN THE THUMB WHEEL STOPPED ROLLING COMPLETELY AND THE PHYSICIAN THEN TRIED TO PULL THE DEPLOYMENT HANDLE; HOWEVER, THE STENT DID NOT DEPLOY. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE DEVICE, BUT A SMALL PORTION OF THE STENT WAS OUTSIDE THE DELIVERY SYSTEM, AND IT CAUGHT ON THE SHEATH WHILE TRYING TO REMOVE THE DEVICE FROM THE PATIENT. THE STENT HAD ELONGATED AND HAD BROKEN INTO THREE PIECES. THE PIECES OF STENT AND THE DELIVERY SYSTEM WERE PULLED OUT WITH THE WIRE STILL IN THE SHAFT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WAS DISPOSED OF AT THE HEALTHCARE FACILITY; THEREFORE, NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17991261 ↗
• MalfunctionSep 21, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE TARGET LESION WAS A 70% STENOSED LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A DISSECTION IN THE MID PORTION, AND ANOTHER 60%-70% LESION IN THE PROXIMAL PORTION. A 6X120X130MM INNOVA VASCULAR STENT WAS ADVANCED TO THE MID SFA LESION AND WAS POSITIONED NICELY. AS THE PHYSICIAN DEPLOYED THE STENT, THE PROXIMAL END OF THE STENT FORESHORTENED 20MM-30MM, BARELY COVERING THE LESION. THEN A 6X100X130 INNOVA VASCULAR STENT WAS ADVANCED TO THE PROXIMAL SFA LESION. AGAIN, AS IT WAS DEPLOYED, THE PROXIMAL END OF THE STENT FORESHORTENED BY 40MM. THE PHYSICIAN WAS NOT SATISFIED WITH THE FORESHORTENING. THE STENTS WERE POST DILATED WITH A MUSTANG BALLOON CATHETER AND UNDER IVUS THEY HAD GOOD VESSEL WALL APPOSITION. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507807 ↗
• MalfunctionApr 29, 2021Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 6X100X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE. WHILE LOADING THE STENT DELIVERY SYSTEM ONTO THE GUIDEWIRE, THE STENT INADVERTENTLY DEPLOYED. THE STENT APPEARED TO BE STUCK ON THE GUIDEWIRE. THE STENT WAS REMOVED FROM THE GUIDEWIRE. A NEW INNOVA STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11747977 ↗
• MalfunctionFeb 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STENT FORESHORTENED. A 6MM X 100MM X 130CM INNOVA SELF EXPANDING STENT WAS SELECTED FOR USE TO TREAT A LESION IN THE LOWER RIGHT LEG. THE INNOVA STENT WAS CORRECTLY DEPLOYED; HOWEVER, THE STENT FORESHORTENED FROM IT'S STATED LENGTH. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS NOT TORTUOUS, NOT CALCIFIED, AND WAS 70% STENOSED. THE LESION WAS PREDILATED AND POST DILATED, AND WAS NOTED AS SIZED CORRECTLY. THERE WAS NO HARM TO THE PATIENT. THE STENT REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11301822 ↗
• MalfunctionAug 24, 2020Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 6X100X103 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE. UPON OPENING THE PACKAGE, THE SHAFT WAS OBSERVED TO BE KINKED AND THE STENT WAS PARTIALLY DEPLOYED FROM THE CATHETER. THE DEVICE WAS NOT USED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10443173 ↗
• MalfunctionMar 20, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY PARTIALLY DEPLOYED. AN 6 X 100 X 130 INOVA, NON-BSC GUIDEWIRE AND NON-BSC SHEATH WERE SELECTED FOR A PROCEDURE. DURING PREPARATION, THE STENT WAS PARTIALLY DEPLOYED 5MM OUTSIDE OF THE DELIVERY CATHETER AFTER IT WAS REMOVED FROM THE PACKAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER INNOVA STENT. THERE WERE NO PATIENT COMPLICATIONS AND THE STENT WAS NEVER INTRODUCED INTO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9860913 ↗
• MalfunctionNov 13, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY BEGAN TO DEPLOY. A 6X100X130 INNOVA SELF-EXPANDING STENT WAS SELECTED TO BE IMPLANTED IN THE LOWER EXTREMITY OF THE PATIENT. THE PHYSICIAN HAD PREVIOUSLY IMPLANTED TWO OTHER STENTS. AS THE DEVICE WAS IN THE PROCESS OF ENTERING THE SHEATH OUTSIDE THE PATIENT, IT BEGAN TO PREMATURELY DEPLOY BEFORE THE SAFETY LOCK HAD BEEN REMOVED. THE STENT DID NOT FULLY DEPLOY. A DIFFERENT DEVICE, WHICH WAS THE SAME MODEL, WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS AND WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9316555 ↗
• MalfunctionMar 27, 2018Entrapment of Device; Entrapment of Device

  SAME CASE AS USER MEDWATCH # 4900320000-2018-8008. IT WAS REPORTED THAT THE STENT WOULD NOT RELEASE FROM THE WIRE. A 6 X 100 X 130 INNOVA SUPERFICIAL FEMORAL ARTERY STENT WAS SELECTED FOR AN ANGIOPLASTY WITH POSSIBLE STENTING. THE STENT WOULD NOT RELEASE FROM THE GUIDEWIRE DURING PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7375291 ↗
• MalfunctionApr 25, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN MODERATELY CALCIFIED AND MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). A 6X100X130 INNOVA¿ WAS INTRODUCED VIA A CONTRALATERAL APPROACH. RESISTANCE WAS FELT DURING ADVANCEMENT INSIDE THE 6F NON BSC INTRODUCER SHEATH AND THE INNOVA¿ WAS UNABLE TO PASS THROUGH THE SHEATH. DURING REMOVAL IT WAS NOTICED THAT THE INNOVA¿ STENT WAS SLIGHTLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6518918 ↗
• MalfunctionMar 16, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR ID #2134265-2017-02149. IT WAS REPORTED THAT WIRE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A TOTALLY OCCLUDED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS PRE-DILATED WITH A 4X200MM MUSTANG BALLOON CATHETER AND THEN WITH A 5X150MM LOTUNIX DRUG COATED BALLOON. A 6 X100X130MM INNOVA STENT WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED. DURING REMOVAL, THE DELIVERY SYSTEM WOULDN¿T COME OFF OF 250 MAGIC TORQUE WIRE SO THE PHYSICIAN HAD TO PULL THE ENTIRE SYSTEM OUT WITH THE WIRE STUCK INSIDE THE DEPLOYMENT SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6411006 ↗

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