AVANTIRecalls & reported problems across all models
Cordis Corporation · 19 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 108
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls
- 1
We found 19 models of AVANTI by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between May 22, 2017 and Sep 8, 2026 — classified as 32 injuries, 76 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (39 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
AVANTI recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 31, 2015Class IITerminated
Incorrect cannula of the sheath introducer (smaller than intended).
Z-1174-2016 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Most reported AVANTI problems
Device problems
- Detachment of Device or Device Component39
- Packaging Problem29
- Device Contamination with Chemical or Other Material10
- Adverse Event Without Identified Device or Use Problem8
- Material Frayed5
- Material Split, Cut or Torn5
- Fracture4
- Manufacturing, Packaging or Shipping Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions84
- No Consequences Or Impact To Patient12
- Obstruction/Occlusion2
- Thrombosis/Thrombus2
- Vascular Dissection2
- Foreign Body In Patient1
- Hematoma1
- Injury1
AVANTI models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AVANTI 504656XDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- AVANTI 504616ZDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION41 reports
- AVANTI 504606XDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION19 reports
- AVANTI 504608XDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION19 reports
- AVANTI 504615ZDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION5 reports
- AVANTI 402606XDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION4 reports
- AVANTI 402605XDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION3 reports
- AVANTI 402605PDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- AVANTI 402607XDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- AVANTI 504658XDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2 reports
- AVANTI 402604XDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- AVANTI 402606PDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- AVANTI 402608ADILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- AVANTI 402608XDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- AVANTI 504505XDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- AVANTI 504506SDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- AVANTI 504607TDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- AVANTI 504608TDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
- AVANTI 504610TDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 report
Recent AVANTI adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674421 ↗MalfunctionSep 8, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674273 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075818 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075814 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075762 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075747 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075739 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075719 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075713 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075707 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075702 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075695 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075689 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074351 ↗MalfunctionMay 4, 2026Packaging Problem
AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074147 ↗
Other Cordis Corporation products
All Cordis Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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