Option Elite Retrievable Vena Cava Filter 352506070ERecalls & reported problems
Argon Medical Devices, Inc. · Option Elite Retrievable Vena Cava Filter Suitable for Jugular or Femoral Delivery - Sterilized at Sterigenics · Class 2 · Implant
All models of Option Elite Retrievable Vena Cava Filter (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886333217519), received between Oct 14, 2021 and Oct 28, 2021 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Component Missing” (2 reports).
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.
Most reported problems
Device problems
- Component Missing2
- Difficult or Delayed Positioning1
- Difficult to Open or Close1
- Difficult to Remove1
- Failure to Advance1
- Fracture1
Patient problems
- Insufficient Information3
- Failure of Implant1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2021Difficult or Delayed Positioning; Difficult to Open or Close
DOING A FILTER PLACEMENT VIA JUGULAR ACCESS AND THE FILTER WAS A LITTLE TOUGH TO PUSH THROUGH THE SHEATH AND WHEN IT CAME OUT OF THE SHEATH IT DIDN'T OPEN. WE RESHEATHED IT AND TOOK IT OUT OF THE PATIENT. WHEN WE OPENED A SECOND FILTER IT PUSHED EASILY AND OPENED AS IT SHOULD.
Patient problems: Failure of Implant
MAUDE report 12715535 ↗MalfunctionOct 19, 2021Fracture; Failure to Advance
FILTER WOULD NOT PASS THROUGH THE SHEATH. SHEATH FRACTURED.
Patient problems: Insufficient Information
MAUDE report 12657881 ↗InjuryOct 19, 2021Difficult to Remove; Component Missing
UPON REMOVAL NOTICED A LEG OF THE FILTER WAS MISSING AND WAS NOT ABLE TO BE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 12657533 ↗MalfunctionOct 14, 2021Component Missing
DURING THE PROCEDURE, UNDER FLUOROSCOPY, THE DOCTOR NOTICED THAT THE RADIOPAQUE MARKER AT THE END OF THE INTRODUCER SHEATH WAS MISSING. THE 2 MARKERS ON THE DILATOR WERE VISIBLE, AND THE DOCTOR WAS FAMILIAR WITH THE OPTION, THAT HE NOTICED THE 3RD MARKER ON THE END OF THE SHEATH WAS NOT THERE. THE SHEATH WAS REMOVED AND ANOTHER OPTION FILTER WAS USED.
Patient problems: Insufficient Information
MAUDE report 12636994 ↗
Other Filter, Intravascular, Cardiovascular devices
- Denali® Vena Cava Filter DL900FBard Peripheral Vascular, Inc. · FILTER, INTRAVASCULAR, CARDIOVASCULAR22 deaths529 reports
- DENALI® Vena Cava Filter DL900JBard Peripheral Vascular, Inc. · FILTER, INTRAVASCULAR, CARDIOVASCULAR15 deaths492 reports
- Option Elite Retrievable Vena Cava Filter System 352506070EArgon Medical Devices, Inc. · Filter, Intravascular, Cardiovascular2 recalls3 deaths342 reports
- Gunther Tulip G33016Cook Incorporated · FILTER, INTRAVASCULAR, CARDIOVASCULAR3 deaths348 reports
- Gunther Tulip G33017Cook Incorporated · FILTER, INTRAVASCULAR, CARDIOVASCULAR3 deaths286 reports
- Cook Celect G34309William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall1 death230 reports
- Gunther Tulip G52916William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths189 reports
- Cook Celect G34502William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths165 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page