Innova™ Vascular H74939293061230Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729874034), received between Dec 8, 2017 and Apr 4, 2023 — classified as 2 injuries, 4 malfunctions.

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

• MalfunctionApr 4, 2023Defective Device; Positioning Problem; Defective Device; Positioning Problem

  IT WAS REPORTED THAT THE STENT DID NOT DEPLOY IN THE INTENDED LOCATION AND APPEARED LONGER ONCE DEPLOYED THAN ON PRE-DEPLOYMENT IMAGING. AN INNOVA VASCULAR STENT WAS SELECTED FOR USE DURING THE PERCUTANEOUS ANGIOPLASTY PROCEDURE. THE TARGET LOCATION WAS LOCATED WITHIN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS REPORTED TO BE 75% STENOSED WITH MODERATE-TO-SEVERE CALCIFICATION. THE STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION, AND THE STENT WAS POSITIONED BY IDENTIFYING BOTH THE PROXIMAL AND DISTAL ENDS ON IMAGING. THE STENT WAS DEPLOYED SLOWLY AND DELIBERATELY, AND THE PROXIMAL END LANDED FAR MORE PROXIMAL THAN THE PRE-DEPLOYMENT IMAGING HAD INDICATED. THE STENT APPEARED MUCH LONGER THAN ORIGINALLY VISUALIZED. FOLLOWING STENT DEPLOYMENT, A POTENTIAL ARTERIOVENOUS FISTULA (AVF) WAS OBSERVED LATERALLY. THE AVF WAS NOT SUSPECTED TO BE RELATED TO THE INNOVA VASCULAR STENT. A CHARGER BALLOON DILATION CATHETER WAS INFLATED TO ADDRESS THE AVF. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16679166 ↗
• InjuryNov 29, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE MARKER BAND DETACHED DURING STENT DEPLOYMENT AND REMAINED IN THE PATIENT. THE PATIENT UNDERWENT A PERIPHERAL ANGIOPLASTY PROCEDURE OF THE RIGHT LOWER EXTREMITY WITH PEDAL ACCESS AND A 6F NON-BSC INTRODUCER. THE MILDLY TORTUOUS TARGET LESIONS WERE SEVERELY CALCIFIED, WITH STENOSIS MEASURING 84% IN THE POSTERIOR TIBIAL (PT), 41% IN THE POPLITEAL ARTERY, AND 93% IN THE SUPERFICIAL FEMORAL ARTERY (SFA). INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO CONFIRM THE CALCIFICATION. THE ROTAPRO 1.75 X 135 WAS SELECTED TO OPEN THE BLOCKAGES. THE SFA WAS PREDILATED USING A CHARGER 5.0 X 120. THE INNOVA 6 X 120 X 130 WAS THEN INSERTED BUT WOULD NOT ADVANCE ALL THE WAY TO DEPLOYMENT SITE. THE INNOVA WAS REMOVED UNDEPLOYED WITH DIFFICULTY. UPON INSPECTION, THE TIP OF THE OUTER RETRACTABLE DEPLOYMENT SHEATH APPEARED BURRED, AND THE PHYSICIAN ELECTED TO REPLACE THE DEVICE WITH ANOTHER STENT RATHER THAN REINSERT. THE PATIENT WAS THEN DILATED USING A COYOTE 2.5 X 120 BALLOON. A NEW INNOVA 6 X 120 X 130 WAS THEN INSERTED WITHOUT RESISTANCE AND DEPLOYED WITHOUT ANY ISSUES. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. THE CHARGER 5.0 X 120 WAS THEN USED TO POST DILATE THE STENT. D

  Patient problems: Foreign Body In Patient

  MAUDE report 15879822 ↗
• 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 12507850 ↗
• MalfunctionNov 26, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT FORESHORTENED. A 6X120X130MM INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE. UPON DEPLOYMENT, THE STENT FORESHORTENED ABOUT 3CM. POST-DILATION WAS PERFORMED USING A 120MM BALLOON WHICH CONFIRMED THE STENT WAS ALMOST 30MM SHORTER. THE FINAL STENT PLACEMENT WAS NOT IDEAL, BUT THE ENTIRE LESION WAS COVERED. POST ANGIOGRAM WAS FINE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9375280 ↗
• InjuryMay 22, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID: 2134265-2018-04458. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2017, THE INDEX PROCEDURE WAS PERFORMED. THE PATIENT PRESENTED WITH CRITICAL ISCHEMIA, REST PAIN, GANGRENE, NON-HEALING ULCERS, AND AMPUTATION OF TOE. AN ANGIOGRAM OF THE RIGHT LEG SHOWED THAT THE RIGHT POPLITEAL ARTERY WAS 70% STENOSED AND THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS 60% STENOSED. A 5MM BY 150MM INNOVA STENT WAS IMPLANTED IN THE RIGHT POPLITEAL ARTERY AND POST-DILATED WITH A 5MM BY 200MM NON-BSC BALLOON. PRETREATMENT STENOSIS WAS 70% AND POST TREATMENT STENOSIS WAS 0%. A 6MM BY 120MM INNOVA STENT WAS IMPLANTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND POST-DILATED WITH A 6MM BY 150MM NON-BSC BALLOON. PRETREATMENT STENOSIS WAS 60% AND POST TREATMENT STENOSIS WAS 0%. THERE WERE NO COMPLICATIONS AND THERE WAS SIGNIFICANT IMPROVED RUNOFF AND FOOT PERFUSION POST INTERVENTION. ON (B)(6) 2018, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS OF BOTH INNOVA STENTS. ATHERECTOMY WAS PERFORMED USING A BSC JETSTREAM 2.4MM ATHERECTOMY CATHETER, FOLLOWED BY BALLOON ANGIOPLASTY WITH A 5MM BY 150MM BSC STERLING BALLOON. THE VESSELS WERE PATENT POST PROCEDURE. THERE WERE NO PATIENT CO

  Patient problems: Reocclusion

  MAUDE report 7535435 ↗
• MalfunctionDec 8, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THE STENT PREMATURELY DEPLOYED IN THE SHEATH. A 6 X 120 X 130 INNOVA¿ WAS SELECTED FOR A PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY. UPON PLACING THE DEVICE INTO THE SHEATH, IT WOULD NOT ADVANCE. AFTER ADVANCING APPROXIMATELY A COUPLE OF MILLIMETERS, IT WOULD NOT MOVE ANY FURTHER, SO THE DEVICE WAS RETRACTED OUT OF THE SHEATH AND REMOVED FROM THE PATIENT. IT WAS OBSERVED THAT PART OF THE STENT HAD STARTED TO DEPLOY WITHIN THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7100644 ↗

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