AVANTI 504607TRecalls & reported problems
Cordis Corporation · SI AVANTI+ 7F MID W/O GW&OBT · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032010085), received between Feb 25, 2025 and Feb 25, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 Puncture/Hole1
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.
InjuryFeb 25, 2025Material Puncture/Hole; Material Puncture/Hole
AS REPORTED, THE UNKNOWN BIOPSY FORCEPS WENT THROUGH 7FR AVANTI + CATHETER SHEATH INTRODUCER (CSI) WALL WHILE IN THE PATIENT. THE PATIENT HAD TO BE ADMITTED WITH FURTHER IMAGING/TREATMENT DONE. HEART BIOPSY PROCEDURE WAS BEING ATTEMPTED VIA RIGHT JUGULAR VEIN ACCESS. THE DEVICE WAS USED AS INTENDED. THERE WERE NO UNUSUAL CIRCUMSTANCES WITH PATIENT OR PROCEDURE/SURGERY. THE DEVICE WAS NOT EXPIRED OR DAMAGED. THE DEVICE WAS NO MISUSED IN ANY WAY. AN UNKNOWN 0.035" 3MM J-TIP 145CM WIRE WAS USED DURING THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21459252 ↗
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
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- 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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