AVIATOR 4244530WRecalls & reported problems
Cordis US Corp. · AVIATOR PLUS .014 4.5X30 142CM · Class 2
Data updated Oct 13, 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 20705032005798), received between Sep 10, 2019 and Sep 10, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2019Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THIS WAS A CAROTID ARTERY STENTING (CAS) CASE, AN AVIATOR PLUS .014 4.5X20 142CM WAS INSERTED FOR POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AFTER A PRECISE STENT WAS IMPLANTED. THE AVIATOR CROSSED THE STENT PATH AND ATTEMPTED TO BE IMPLANTED; HOWEVER, THE AVIATOR RUPTURED WITHIN ITS NOMINAL PRESSURE. THERE WERE NO REPORTED PATIENT INJURIES. THE AVIATOR WAS REPLACED WITH A NEW AVIATOR PLUS 4.5MM*3CM AND IT WAS INFLATED, AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE RIGHT CAROTID ARTERY WITH STENOSIS. AN APPROACH WAS MADE FROM THE INGUINAL REGION WITH A NON-CORDIS GUIDING SHEATH, AND THEN IT WAS ADVANCED TO THE COMMON CAROTID ARTERY. A NON-CORDIS GUARDWIRE WAS ADVANCED TO THE DISTAL PORTION OF THE INTERNAL CAROTID ARTERY. THE PATIENT HAD NO INFECTIOUS DISEASE. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS STORED IN THE BOX, AND BROUGHT TO THE CATH LAB ON THE DAY OF THE PROCEDURE. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY RE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8983598 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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