Innova™ Vascular H74939293054030Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729873907), received between Apr 12, 2017 and Jul 22, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (7 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.

• MalfunctionJul 22, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25907172 ↗
• MalfunctionNov 6, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. A 5 X 40 X 130 INNOVA SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PREPARATION, THE STENT APPEARED TO BE PARTIALLY DEPLOYED AFTER FLUSHING THE BACK END. IT WAS UNCERTAIN WHETHER THE STENT WAS ALREADY PARTIALLY DEPLOYED PRIOR TO FLUSHING OR IF THE FLUSHING PROCESS CAUSED THE ISSUE. 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 23486669 ↗
• MalfunctionDec 3, 2024Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 5 X 40 X 130 INNOVA VASCULAR STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE INNOVA WAS ADVANCED ONTO THE 035 BOSTON SCIENTIFIC GUIDEWIRE. A SLIGHT BEND WAS OBSERVED AT THE BACK END OF THE GUIDEWIRE. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING INTO THE SHEATH. UPON REACHING APPROXIMATELY 5 CM FROM THE TARGET LESION, IT WAS NOTED THAT THE STENT HAD BEGUN DEPLOYING PREMATURELY, DESPITE THE YELLOW SAFETY MECHANISM REMAINING INTACT. UPON REMOVAL FROM THE SHEATH, THE STENT WAS FOUND TO HAVE FULLY DEPLOYED ONTO THE DELIVERY SHAFT AND WAS SUCCESSFULLY REMOVED FROM THE BODY. THE DELIVERY SYSTEM APPEARED TO BE FULLY INTACT. AN ADDITIONAL INNOVA OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834670 ↗
• MalfunctionJul 1, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT AN INADVERTENT DEPLOYMENT OCCURRED. A 5 X 40 X 130 INNOVA STENT WAS SELECTED FOR TREATMENT. HOWEVER, THE STENT WAS NEVER REMOVED FROM ITS STERILE POUCH AS IT WAS NOTED TO BE PARTIALLY DEPLOYED PRIOR TO PREPARATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645860 ↗
• MalfunctionMay 17, 2022Mechanical Problem; Premature Activation; Mechanical Problem; Premature Activation

  IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN A CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5 X 40 X 130 INNOVA STENT WAS SELECTED FOR THE STENTING PROCEDURE. WHEN PREPPING THE STENT WITH SALINE, IT WAS STATED THAT THE SAFETY LOCK WAS LOOSE AND CAME OFF BEFORE PLACING THE STENT ON THE WIRE. WHEN LOADING THE STENT ONTO THE WIRE, THE THUMBWHEEL ACTIVATED AND PARTIAL DEPLOYMENT OF THE STENT OCCURRED OUTSIDE OF THE PATIENT. THE STENT WAS DISCARDED AND REPLACED WITH ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14415304 ↗
• InjuryMay 23, 2019Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT PREMATURE STENT DEPLOYMENT OCCURRED. A 5X40X130 INNOVA STENT WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE INNOVA STENT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN WAS REMOVING THE DEVICE FROM THE PATIENT WHEN THE STENT BEGAN TO DEPLOY. THE PHYSICIAN ENDED UP PULLING THE STENT BACK TO THE COMMON FEMORAL ARTERY AND DEPLOYING THE STENT IN THIS LOCATION. THE PATIENT WILL REQUIRE BYPASS SURGERY TO REMOVE THE STENT AS WELL AS TO BYPASS THE HEAVILY CALCIFIED AREA. THE PATIENT IS IN FINE CONDITION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8638569 ↗
• MalfunctionJul 5, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 5X40X130 INNOVA STENT WAS SELECTED FOR USE DURING A STENT PLACEMENT PROCEDURE IN THE PATIENT'S LEFT POPLITEAL ARTERY. DURING THE PROCEDURE, INSIDE OF THE PATIENT, THE DEVICE STARTED DEPLOYING AS SOON AS THE STENT DELIVERY SYSTEM WAS INSERTED THROUGH THE HUB OF THE SHEATH. THIS OCCURRED BEFORE THE PHYSICIAN INTENTIONALLY STARTED THE DEPLOYMENT PROCESS. THE PHYSICIAN WAS ABLE TO RETRIEVE THE STENT AND THE PATIENT WAS NOT HARMED. A 5X60 INNOVA STENT WAS THEN USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS AFTER THE PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7664407 ↗
• InjuryMay 8, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2017, THE INDEX PROCEDURE WAS PERFORMED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD), CRITICAL ISCHEMIA, REST PAIN, CLAUDICATION, AND WEAKNESS. AN ANGIOGRAM OF THE RIGHT LEG SHOWED THAT THE RIGHT POPLITEAL ARTERY WAS OCCLUDED. THE RIGHT POPLITEAL ARTERY WAS BALLOON DILATED WITH A 2MM BY 220MM BSC STERLING BALLOON. PRE-TREATMENT STENOSIS WAS 100% AND POST-TREATMENT STENOSIS WAS 99%. THE RIGHT POPLITEAL ARTERY WAS THEN ATHERECTOMIZED WITH A BSC JETSTREAM2.1/3.0MM ATHERECTOMY CATHETER. PRE-TREATMENT STENOSIS WAS 99% AND POST-TREATMENT STENOSIS WAS 70%. THE RIGHT POPLITEAL ARTERY WAS BALLOON DILATED AGAIN WITH A 5MM BY 200MM BSC STERLING BALLOON. PRE-TREATMENT STENOSIS WAS 70% AND POST-TREATMENT STENOSIS WAS 50%. THE DISTAL RIGHT POPLITEAL ARTERY WAS BALLOON DILATED AGAIN WITH A NON-BSC 4MM BY 150MM BALLOON. PRE-TREATMENT STENOSIS WAS 50% AND POST-TREATMENT STENOSIS WAS 0%. AN ANGIOGRAM OF THE RIGHT POPLITEAL ARTERY WAS PERFORMED AND IT WAS FOUND THAT THE REMAINDER OF THE ARTERY WAS 40% STENOSED WITH CALCIFICATION, PLAQUE, AND DISSECTION. THE RIGHT POPLITEAL ARTERY WAS CATHETERIZED AND AN INTRAVASCULAR ULTRASOU

  Patient problems: Reocclusion

  MAUDE report 7495955 ↗
• InjuryMay 8, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID# 2134265-2018-04115. THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS OF THE 5.0 X 40 X130 INNOVA STENT THAT WAS PLACED IN THE RIGHT POPLITEAL ARTERY ON (B)(6) 2017. THE ISR WAS TREATED WITH ATHERECTOMY AND BALLOON ANGIOPLASTY, RESULTING IN A PATENT RIGHT POPLITEAL. IT WAS ALSO OBSERVED IN THE SAME PROCEDURE THAT IN-STENT RESTENOSIS OCCURRED IN THE 6.0 X 150 X 130 INNOVA STENT THAT WAS PLACED IN THE RIGHT SFA ON (B)(6) 2017. THE ISR WAS TREATED WITH ATHERECTOMY AND BALLOON ANGIOPLASTY, RESULTING IN A PATENT RIGHT SFA. NO FURTHER PATIENT COMPLICATIONS OCCURRED AND PATIENT STATUS POST-PROCEDURE WAS GOOD.

  Patient problems: Reocclusion

  MAUDE report 7495836 ↗
• InjuryMar 23, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR 2134265-2018-02326. IT WAS REPORTED THAT IN STENT RESTENOSIS OCCURRED. THE PATIENT PRESENTED WITH CRITICAL ISCHEMIA, REST PAIN AND CLAUDICATION. ON (B)(6) 2017, THE INDEX PROCEDURE WAS PERFORMED. AN ULTRASOUND IN THE RIGHT POPLITEAL ARTERY WAS PERFORMED AND REVEALED 50% STENOSIS WITH PLAQUE AND INTIMAL HYPERPLASIA. A 5X40 INNOVA¿ STENT WAS PLACED SUCCESSFULLY IN THE RIGHT POPLITEAL ARTERY. POST-DILATAION WAS PERFORMED WITH A NON-BSC BALLOON. POST-TREATMENT STENOSIS WAS 0%. THE PROCEDURE WAS COMPLETED WITH A GOOD RESULT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. ON (B)(6) 2018, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS IN THE INNOVA STENT. ON (B)(6) 2018, ATHERECTOMY WITH A 2.4 MM JETSTREAM® XC ATHERECTOMY CATHETER AND BALLOON ANGIOPLASTY WERE PERFORMED THROUGH THE OCCLUDED STENT. THERE WAS A GREAT OUTCOME AND THE STENT WAS PATENT. THIS WAS CONFIRMED THROUGH IVUS. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS DOING WELL.

  Patient problems: Reocclusion

  MAUDE report 7365729 ↗
• MalfunctionApr 12, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. DURING PREPARATION OF AN 5 X40 X130 INNOVA¿, A .35MM NON BSC WIRE BECAME ENTRAPPED ON THE STENT AND INADVERTENTLY THE STENT DEPLOYED. ANOTHER STENT WAS SELECTED FOR USE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6486036 ↗

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