Innova™ Vascular H74939293071530Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729874133), received between Mar 21, 2017 and Sep 6, 2024 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT OCCURRED. A 7 X 150 X 130 INNOVA VASCULAR STENT SELF-EXPANDING WAS SELECTED FOR USE. WHEN THE PACKAGE WAS OPENED, THE STENT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157942 ↗
• MalfunctionJun 7, 2024Premature Activation; Material Integrity Problem; Premature Activation; Material Integrity Problem

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. THE PATIENT UNDERWENT A ROTATIONAL ATHERECTOMY TO DILATE A TRACK WHERE THE TARGET LESION WAS HEAVILY CALCIFIED. A 6MMX150MM STERLING BALLOON CATHETER WAS SELECTED TO POST-INFLATE THE VESSEL. DURING THE PROCEDURE, THE BALLOON RUPTURED DUE TO THE CALCIFICATION. PLACEMENT OF A 7 X 150 X 130 INNOVA STENT FOLLOWED. THE DEVICE WAS WHEELED INTO THE PATIENT UNTIL IT SUCCESSFULLY DEPLOYED. WHEN THE BLUE ARROW INDICATED IT WAS CLEAR, THE PHYSICIAN ATTEMPTED TO PULL THE HANDLE BACK, BUT IT WAS STUCK FROM THE START POSITION AND THE STENT WAS ALREADY VISIBLY DEPLOYED. THE CATHETER OF THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THE HANDLE WOULD NOT RETRIEVE WHEN TRYING TO PULL IT. THE STENT FULLY DEPLOYED WITHOUT PULLING THE BLUE PLUNGER BACK. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492044 ↗
• MalfunctionJun 13, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL SUPERFICIAL FEMORAL ARTERY. FOLLOWING THE USE OF THE ROTABLATOR, A 7 X 150 X 130 CM INNOVA VASCULAR STENT SYSTEM WAS SELECTED TO BE DEPLOYED IN THE LESION. THE INNOVA WAS ADVANCED OVER THE ROTAWIRE, AND THE THUMBWHEEL WAS TURNED UNTIL THE WHITE ARROW APPEARED; HOWEVER, THE SHAFT WAS UNABLE TO BE PULLED TO COMPLETE DEPLOYMENT. THE WIRE WOULD NOT ADVANCE OR WITHDRAW, AND THE STENT WAS PARTIALLY DEPLOYED, SO THE DECISION WAS MADE TO SEPARATE THE WHITE HOUSING AND USE A PIN AND PULL METHOD OF DEPLOYMENT TO COMPLETE THE STENT DEPLOYMENT. THE ORIGINAL STENT WAS USED TO COMPLETE THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14682534 ↗
• MalfunctionAug 23, 2020Entrapment of Device; Failure to Advance; Material Deformation; Entrapment of Device; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS STUCK ON THE GUIDEWIRE. A 7MM X 150MM INNOVA SELF EXPANDING STENT WAS SELECTED FOR AN ENDOVASCULAR THERAPY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY. A NON-BSC 0.035" GUIDEWIRE WAS ALSO USED. THE INNOVA WAS INSERTED FROM THE OPPOSITE SIDE OF THE LEG, AND THERE WAS DIFFICULT ADVANCING. THE DEVICE ULTIMATELY FAILED TO CROSS THE LESION. THE DEVICE BECAME STUCK ON THE GUIDEWIRE AND COULD NOT BE REMOVED. THE INNOVA AND GUIDEWIRE WERE THEREFORE REMOVED TOGETHER. THE GUIDEWIRE'S SHAFT WAS NOTED TO BE KINKED UPON REMOVAL. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10440666 ↗
• InjuryMar 30, 2020Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND THE STENT STRETCHED IN THE PATIENT'S ANATOMY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LESION SUPERFICIAL FEMORAL ARTERY (SFA). A CONTRALATERAL APPROACH WAS USED TO ACCESS THE LESION. PRE-DILATION WAS PERFORMED. A 7X150X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE OVER .014/300 CM NON-BSC GUIDEWIRE. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS UNABLE TO BE FULLY DEPLOYED USING THE THUMBWHEEL DESPITE USING MUCH FORCE. THE PULL GRIP WAS ATTEMPTED TO BE USED. THE CATHETER WAS PULLED BACK AND THE STENT BECAME STRETCHED INTO THE EXTERNAL ILIAC ARTERY. A SHEATH DILATOR WAS USED TO PUSH THE DEPLOYMENT CATHETER OUT WITH THE STENT REMAINING IMPLANTED AND STRETCHED WITHIN THE ANATOMY. THE STENT WAS NOT ABLE TO BE REMOVED. THERE WERE NO IMMEDIATE PATIENT COMPLICATIONS. HOWEVER, THE STENT NOW SITS ACROSS THE COMMON FEMORAL ARTERY (CFA), AN AREA THAT BENDS AND SHOULD NOT BE STENTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9898137 ↗
• MalfunctionAug 12, 2019Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem; Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT THE STENT JUMPED FORWARD AND ELONGATED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED AND NORMALLY TORTUOUS LEFT COMMON ILIAC AND EXTERNAL ILIAC ARTERIES. AN IPSILATERAL APPROACH WAS USED TO ACCESS THE LESION. A BSC 6F SUPER SHEATH WAS USED FOR ACCESS AND A NON-BSC WIRE WAS SELECTED. PRE-DILATION WAS PERFORMED WITH A 5MM BALLOON, HOWEVER, PRE-DILATION DID NOT OPEN THE LESION LARGE ENOUGH. A 7 X 150 X 130 INNOVA VASCULAR STENT WAS SELECTED FOR USE WITHIN THE LEFT COMMON ILIAC TO THE DISTAL PORTION OF THE EXTERNAL ILIAC ARTERY. DURING DEPLOYMENT, THE STENT JUMPED FORWARD AND ELONGATED. WHEN BEGINNING TO DEPLOY, THE STENT MOVED FORWARD THROUGH A HIGH GRADE STENOSIS OF THE LEFT COMMON ILIAC. THE STENT DEPLOYED WITHOUT ISSUE FOR 30-40MM, BUT THEN ONCE THE STENT HIT THE HIGH GRADE STENOSIS IT ELONGATED FOR ABOUT 30MM BEFORE RETURNING BACK TO LOOKING NORMAL AND NOT ELONGATED. NO STENT FACTURE WAS NOTED. DUE TO THE ELONGATION, THE END OF THE STENT COMPLETED DEPLOYMENT WITHIN THE SHEATH. BY PULLING THE SHEATH BACK A FEW MILLIMETERS, THE STENT WAS ABLE TO DEPLOY AND PROPERLY EXPAND INSIDE OF THE COMMON FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED BY P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8884016 ↗
• MalfunctionMar 19, 2019Entrapment of Device; Difficult to Remove; Failure to Advance; Entrapment of Device; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE INNOVA DELIVERY SYSTEM WAS STUCK ON THE WIRE. A MAGIC TORQUE GUIDEWIRE AND A 7X150X130 INNOVA VASCULAR STENT WERE SELECTED FOR A STENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE INNOVA DEVICE. THE INNOVA STENT WAS DEPLOYED SAFELY INTO THE PATIENT. THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE AND BECAME STUCK ON THE MAGIC TORQUE GUIDEWIRE. EVERYTHING WAS REMOVED TOGETHER. THE PHYSICIAN LOST WIRE POSITION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8433889 ↗
• MalfunctionMar 13, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE AND BROKE. DURING THE LOWER EXTREMITY STENTING PROCEDURE, A STENT WAS SUCCESSFULLY DEPLOYED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A 7X150X130 INNOVA STENT WAS THEN PLACED IN THE LEFT PROXIMAL SFA SUCCESSFULLY. WHEN THEY WERE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT, THEY NOTICED THAT THE DELIVERY SYSTEM WAS TIGHT ON THE WIRE. THEY CONTINUED TO PULL ON THE DEVICE AND THE CATHETER BROKE, BUT STAYED ON THE WIRE. EVERYTHING WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8417085 ↗
• MalfunctionOct 30, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE STENT BECAME STUCK ON THE WIRE. A 7X150X130 INNOVA STENT WAS SELECTED FOR USE. THE STENT WAS DEPLOYED, HOWEVER, THE INNER LUMEN OF THE INNOVA BECAME STUCK ON THE NON-BSC GUIDEWIRE. THE DEVICE WAS ATTEMPTED TO BE REMOVED FROM THE GUIDEWIRE BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN FORCEFULLY BROKE APART THE INNOVA DELIVERY SYSTEM AND WAS ABLE TO REMOVE THE ENTIRE SYSTEM IN PIECES, AND THE GUIDEWIRE WAS REMOVED AS WELL. A NEW GUIDEWIRE WAS INSERTED AND THE PROCEDURE WAS COMPLETED BY BALLOONING THE INNOVA. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8020625 ↗
• MalfunctionApr 2, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE DEVICE BECAME STUCK ON THE WIRE. A 7 X 150 X 130 INNOVA¿ STENT WAS SELECTED FOR A PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE STENT WAS DEPLOYED WITHOUT ISSUE. DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS), THE SDS BECAME STUCK ON THE .035 NON-BSC WIRE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NON-BSC WIRE AND AN ADDITIONAL INNOVA STENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7389167 ↗
• InjuryMar 21, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT WAS SHORTER THAN EXPECTED ONCE DEPLOYED. VASCULAR ACCESS WAS OBTAINED VIA THE POPLITEAL. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MINOR TORTUOUS AND MODERATELY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING POST-DILATION, A 7X150X130 INNOVA¿ STENT WAS ADVANCED AND DEPLOYED WITHOUT ISSUES. AFTER DEPLOYMENT, IT APPEARED THE STENT WAS ONLY 100MM IN LENGTH. A 6X150 BALLOON CATHETER WAS PLACED ACROSS THE STENT AND IT WAS NOTED THAT THE BALLOON WAS 4-5CM LONGER THAN THE STENT. A 7X80X130 INNOVA¿ STENT WAS DEPLOYED IN NORMAL FASHION WITH APPROPRIATE OVERLAP OF THE FIRST STENT PLACED, FOLLOWED BY POST DILATAION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH GOOD DISTAL RUN OFF AND FULL STENT EXPANSION. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7360020 ↗
• MalfunctionMar 13, 2018Bent; Bent

  IT WAS REPORTED THE STENT FORESHORTENED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED NON-TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. A 0.035 NON-BSC GUIDEWIRE WAS PLACED AND THE LESION WAS PRE-DILATED. A 7 X 150 X 130 INNOVA¿ STENT WAS SELECTED FOR USE AND DEPLOYMENT WAS INITIATED INSIDE THE PATIENT. DURING DEPLOYMENT, THE STENT FORESHORTENED ABOUT 5-10MM FROM PRE-DEPLOYMENT LENGTH. THERE WERE NO ISSUES WITH THE HANDLE DURING DEPLOYMENT. POST DILATION WAS PERFORMED ON THE DEPLOYED STENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7334770 ↗
• InjuryDec 21, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) THAT MEASURED 142MM IN LENGTH. PRE-DILATION WAS PERFORMED WITH A 5X120 NON-BSC BALLOON CATHETER, FOLLOWED BY THE ADVANCEMENT OF A 7 X 150 X 130 INNOVA¿ STENT OVER A V18 GUIDEWIRE VIA AN ANTEGRADE APPROACH. THE STENT WAS DEPLOYED WITHOUT ANY NOTED DIFFICULTIES; HOWEVER UPON DEPLOYMENT THE STENT WAS SEVERELY FORESHORTENED LEAVING A PORTION OF THE LESION UNCOVERED. THE DEPLOYED STENT MEASURED APPROXIMATELY 115MM. ADDITIONAL STENTING WITH A 7X60 NON-BSC STENT WAS REQUIRED TO COVER THE REMAINING LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7140051 ↗
• MalfunctionDec 18, 2017Entrapment of Device; Stretched; Activation, Positioning or Separation Problem; Entrapment of Device; Stretched; Activation, Positioning or Separation Problem

  SAME CASE AS MDR ID 2134265-2017-12415. IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT, STENT ELONGATION AND CATHETER ENTRAPMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 6F NON BSC INTRODUCER SHEATH WAS ADVANCED TO THE RIGHT COMMON FEMORAL ARTERY (CFA) WITHOUT DIFFICULTY BY LEFT BRACHIAL APPROACH. THERE WAS NO PARTICULAR SEVERE TORTUOSITY IN THE LEFT SUBCLAVIAN, AORTA, EXTERNAL ILIAC ARTERY AND SFA. PRE DILATATION WAS PERFORMED USING A 6.0X100 NON BSC BALLOON CATHETER. SUBSEQUENTLY, A 6.0X200 NON BSC STENT WAS PLACED IN THE DISTAL SFA. A 7X150X130 INNOVA¿ STENT DELIVERY SYSTEM WAS THEN ADVANCED OVER A 300CM JOURNEY¿ GUIDEWIRE TO THE TARGET LESION WITHOUT RESISTANCE. THERE WAS NO STEEP TORTUOSITY AND CALCIFICATION NOTED. STENT DEPLOYMENT WAS THEN INITIATED. DEPLOYMENT OF THE STENT STARTED SMOOTHLY THEN ABOUT HALFWAY FROM RELEASING, THE FORCE THAT ROTATES THE THUMBWHEEL BECAME GRADUALLY HARDER. ABOUT 5CM OF THE STENT WAS NOT RELEASED EVEN AFTER FULLY DEPLOYING THE THUMBWHEEL AND PULL GRIP. THE PHYSICIAN THEN PULLED BACK THE ENTIRE DELIVERY SYSTEM TO RELEASE AND DEPLOY THE STENT. APPRO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7127226 ↗
• MalfunctionDec 8, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR ID# 2134265-2017-11948. IT WAS REPORTED THAT THE GUIDEWIRE BECAME ENTRAPPED ON THE STENT DELIVERY SYSTEM. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 7X150X130 INNOVA¿ STENT SYSTEM WAS ADVANCED OVER A MAGIC TORQUE GUIDEWIRE AND THE INNOVA¿ WAS SUCCESSFULLY DEPLOYED. DURING REMOVAL, THE INNOVA DELIVERY SYSTEM COULD NOT BE REMOVED OVER THE GUIDEWIRE. THE GUIDEWIRE AND DELIVERY SYSTEM WERE REMOVED TOGETHER AS ONE UNIT. IT WAS NOTED THAT THE GUIDEWIRE MAY HAVE BEEN KINKED. A NEW GUIDEWIRE WAS PLACED AND ANOTHER STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION POST PROCEDURE IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7100599 ↗
• MalfunctionMar 21, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DEPLOYMENT DIFFICULTY OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 7X150X130 INNOVA¿ STENT WAS ADVANCED CONTRALATERALLY TO THE LESION AND DEPLOYMENT WAS INITIATED VIA SLIGHT ROTATION OF THE THUMB WHEEL, HOWEVER HIGH FORCE WAS REQUIRED TO TURN THE WHEEL. AFTER THE THUMB WHEEL WAS ROTATED, THE PHYSICIAN DEPLOYED THE STENT USING THE PULL GRIP AND IT WAS NOTED TO BE DIFFICULT; HOWEVER, THE STENT WAS STILL ABLE TO BE DEPLOYED WITH FORCE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6422793 ↗

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