AVANTI 504610TRecalls & reported problems
Cordis Corporation · SI AVANTI+ CSI 10F W/O MINI GW · Class 2
All models of AVANTI (19)
Data updated Oct 16, 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 10705032010214), received between Dec 2, 2025 and Dec 2, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
InjuryDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, A 10F AVANTI+ SHEATH INTRODUCER W/O MINI GW 23CM FRAGMENTED INTO TWO DISTINCT PIECES DURING ROUTINE REMOVAL FOLLOWING PULMONARY VEIN ISOLATION AND POSTERIOR WALL ISOLATION WITH PULSED FIELD ABLATION, RESULTING IN A RETAINED FOREIGN BODY THAT REQUIRED RIGHT GROIN EXPLORATION WITH A CUTDOWN TO THE RIGHT FEMORAL VEIN FOR SURGICAL REMOVAL. THERE WAS A REPORTED PATIENT INJURY OF A RETAINED FRAGMENT REQUIRING SURGICAL INTERVENTION. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692654 ↗
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
- Abiomed® 00884450732311Merit Medical Systems, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall1 report
- Mini Stick MAX H965457510Angiodynamics, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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