Innova™ Vascular H74939293058030Recalls & reported problems
Boston Scientific Corporation · Self-Expanding Stent System · Class 3 · Implant
All models of Innova Vascular (42)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729873921), received between May 6, 2022 and May 6, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (1 report).
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
Device problems
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2022Premature Activation; Premature Activation
IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 5MMX 80MM X 130CM INNOVA VASCULAR STENT WAS SELECTED FOR A SUPERFICIAL FEMORAL ARTERY INTERVENTION PROCEDURE. UPON REMOVING THE INNOVA VASCULAR STENT FROM THE PACKING HOOP, IT WAS OBSERVED THAT THE STENT WAS DEPLOYED OUTSIDE OF THE DEPLOYMENT SHAFT. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14310787 ↗
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, ClassifiedInnova 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, ClassifiedInnova 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
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page