AVANTI 402608XRecalls & reported problems
Cordis Corporation · SI AVANTI+ .035 F8 W/MINI GW · Class 2
All models of AVANTI (19)
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 10705032000703), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K970392); 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.
Reports received per month
Most reported problems
Device problems
- Material Frayed1
- Material Split, Cut or Torn1
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.
MalfunctionMar 18, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn
AS REPORTED, THE 8F .035 AVANTI SHEATH INTRODUCER WITH MINI-GUIDEWIRE WAS FOUND TO HAVE A CREASE AFTER UNPACKING. THE DEVICE COULD NOT BE USED. ANOTHER AVANTI SHEATH WAS USED TO COMPLETE THE CEREBRAL ANGIOGRAPHY PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO REMOVING THE DEVICE FROM THE STERILE PACKAGING OR DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS RETURNED FOR EVALUATION. DURING PRODUCT ANALYSIS THE DISTAL TIP AREA OF THE CANNULA WAS INSPECTED CONFIRMING A FRAYED CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18926817 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K970392. One submission often covers many models, so check the product and lot details in each record.
- Z-2079-2021 · Jun 9, 2021 · TerminatedAvanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
- Z-1174-2016 · Dec 31, 2015 · TerminatedCORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneo
Other DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION devices
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization3 deaths108 reports
- TandemLife 5740-2417Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 recalls0 reports
- TightRail Rotating Dilator Sheath 545-513Spectranetics Corporation · Dilator, Vessel, For Percutaneous Catheterization20 deaths74 reports
- VersaCross Connect LAAC Access Solution VXAK0003Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths70 reports
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths54 reports
- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
- Abiomed® 00884450732311Merit Medical Systems, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall1 report
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.
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