Option Elite Retrievable Vena Cava Filter 352506100ERecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00886333222346), received between Oct 1, 2020 and Jul 1, 2025 — classified as 9 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Break; Break

  REPORT RECEIVED VIA MEDSUN REPORTING "SURGEON DEPLOYED INITIAL IVC [INFERIOR VENA CAVA] FILTER WHICH MALFUNCTIONED, SURGEON REMOVED THE DEVICE AND CONFIRMED VIA XRAY THAT NO PIECES OF THE DEVICE REMAINING WITHIN THE PT, SURGEON THEN DEPLOYED SECOND IVC FILTER WHICH REMAINED IMPLANTED IN PT. NO HARM TO PATIENT." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATING THE SAMPLE IS NOT AVAILABLE FOR RETURN, IMAGES ARE NOT AVAILABLE, AND THE IVC FILTER INSERTION AREA WAS THE LEFT POSTERIOR UPPER LEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373942 ↗
• MalfunctionJun 20, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  OPTION ELITE IVC FILTER PLACEMENT VIA BRACHIAL APPROACH, 100CM KIT. THE PATIENT HAD SCOLIOSIS, AND PRONOUNCED CURVATURE TO THE IVC WAS PRESENT. THE OTW TECHNIQUE WAS ATTEMPTED; THE WIRE WOULD NOT LOAD THROUGH THE FILTER CARTRIDGE. ATTEMPTED TO LOAD THE WIRE THROUGH THE OTHER END OF THE CARTRIDGE TO SEE IF IT WOULD LOAD AND POTENTIALLY OPEN UP THE PASSAGEWAY...IT DID PASS. THINKING THIS OPENED IT UP, THE WIRE WAS PASSED THROUGH THE CARTRIDGE IN THE APPROPRIATE DIRECTION, BUT IT WOULD NOT GO SMOOTHLY. THE WIRE FROM THE PATIENT WAS REMOVED, AND THE OTW TECHNIQUE WAS ABANDONED. THE CARTRIDGE WAS LOADED, SNAPPED ONTO THE DELIVERY SHEATH, AND THE PUSHER WAS USED. NO RESISTANCE WAS FELT, AND THE FILTER WAS DEPLOYED. UPON DEPLOYMENT, THE LEGS WOULD NOT OPEN. ATTEMPTS WERE MADE TO OPEN THE LEGS. AT ONE, EACH INDIVIDUAL LEG WAS SEEN (NOT TANGLED) BUT WOULDN'T FULLY EXPAND. THE FILTER WAS RETRIEVED WITH ARGON RK VIA JUGULAR, AND A NEW OE (70CM FILTER VIA 100CM KIT THROUGH RK KIT) WAS PLACED VIA JUGULAR APPROACH. PRIOR TO 2ND PLACEMENT, THE CURVATURE OF THE IVC WAS MARKED ON THE SCREEN TO AVOID PLACEMENT IN THE CURVATURE. THE FILTER WAS PLACED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301913 ↗
• MalfunctionMay 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  THE DOCTOR REPORTED WHILE ATTEMPTING TO PLACE AN OE FILTER VIA BRACHIAL ACCESS UTILIZING AN OTW TECHNIQUE. AFTER DELIVER SHEATH WAS POSITIONED, WHEN USING THE DILATOR TO PUSH THE FILTER, RESISTANCE WAS MET WHEN THE FILTER REACHED THE BRACHIAL/SVC JUNCTION. THE FILTER WOULD NOT ADVANCE AND THE DILATOR WAS REMOVED. NEXT, THE DELIVERY SHEATH WAS PULLED OUT WITH WIRE (STIFF GLIDE) STILL IN IN PLACE. AFTER INSPECTING THE SHEATH AND NOT SEEING THE FILTER IT WAS REALIZED THAT THE FILTER HAD DEPLOYED WHEN PULLING OUT THE DELIVERY SHEATH. THE FILTER HAD DEPLOYED AT THE AXILLARY JUNCTION. THE FILTER WAS SNARED AND REMOVED. A SECOND ATTEMPT WITH NEW OE WAS ATTEMPTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274499 ↗
• MalfunctionApr 3, 2024Difficult to Advance; Difficult to Advance

  A CUSTOMER REPORTED THAT DURING AN IVC FILTER PLACEMENT PROCEDURE IN THE PATIENTS RIGHT BRACHIAL VEIN, THE FILTER HAD RESISTANCE WHEN ADVANCING THE CARTRIDGE OTW AND AGAIN WHEN USING THE DILATOR TO PUSH THE FILTER INTO AND THROUGH THE SHEATH. WHEN THE FILTER WAS IN THE SHEATH AND NEAR THE CEPHALIC ARCH, THE FILTER GOT STUCK AND WOULD NOT ADVANCE. ALL COMPONENTS WERE REMOVED AND THE FILTER HAD KINKED AND STARTED TO PIERCE THROUGH THE SIDE OF THE DEPLOYMENT SHEATH. A NEW KIT WAS USED AND THE FILTER WAS PLACED SUCCESSFULLY WITH SOME RESISTANCE IN THE SAME CEPHALIC ARCH AREA. IT WAS NOTICED THAT THERE WAS NO PIN IN THE FILTER/CARTRIDGE OUT OF THE PACKAGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038363 ↗
• MalfunctionDec 2, 2023Activation Problem; Activation Problem

  OPTION ELITE IVC FILTER WAS UNSHEATHED IN THE IVC AND THE PROVIDER COMMENTED THAT, ¿AT LEAST TWO OF THE LEGS WERE TANGLED TOGETHER¿. THE FILTER WAS RETRIEVED AND A NEW OPTION ELITE WAS DEPLOYED WITH OUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253190 ↗
• MalfunctionOct 2, 2023Activation Problem; Activation Problem

  DR. (B)(6) WENT BRACHIAL TO PLACE IVC FILTER WITH 100CM OPTION ELITE. FILTER WAS PLACED BUT DID NOT EXPAND. ALLOWED TIME TO PASS BUT LEGS STAYED COLLAPSED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858333 ↗
• MalfunctionSep 27, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  100CM SHEATH WOULD NOT ADVANCE, GOT STUCK IN SFV, THEN SHEARED APART WHEN IT WAS REMOVED. SURGEON HAD TO CUT DOWN TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825864 ↗
• MalfunctionJun 20, 2022Fracture

  OPTION ELITE FILTER WAS BEING RETRIEVED. DOCTOR WAS ABLE TO SNARE THE OPTION FILTER, BUT THE TOP PART FRACTURED OFF LEAVING THE FILTER BEHIND. PATIENT IS 75 AND THE FILTER WAS NOT REMOVED. UPDATE: THE INITIAL VENOGRAM SHOWED THAT A TINE HAD COME OFF OF THE HOOK END OF THE FILTER. DR. STANLEY WAS ABLE TO SNARE THE END AND TRIED TO CAPTURE THE FILTER BUT WAS UNABLE TO. THE FILTER WAS THEN LEFT IN PLACE AND THE PROCEDURE WAS ENDED. AS FAR AS THE LENGTH, WE DID BRING IN A SMALL NUMBER OF SHORTER MODELS TO TRIAL AT FIRST. THE RADIOLOGISTS DECIDED TO ONLY BRING THE LONGER LENGTH IN BECAUSE OF ITS UNIQUE APPLICATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 14743031 ↗
• MalfunctionMay 24, 2022Activation Failure

  THE CUSTOMER SAID THAT THE OPTION FILTER WOULD NOT DEPLOY. THEY SAID THAT THEY USE THE CURVED PUSHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488893 ↗
• MalfunctionSep 23, 2021Difficult to Remove; Detachment of Device or Device Component

  WHILE REMOVING THE DILATOR FROM THE OPTION ELITE IVC FILTER DEPLOYMENT SHEATH, THE DISTAL MARKER OF THE DILATOR CAME OFF AGAINST THE SHEATH TIP AND EMBOLIZED TO THE PATIENT'S RIGHT LUNG. THE DILATOR REMOVAL WAS DONE OVER AN AMPLATZ WIRE AND IN A SMOOTH FASHION WITHOUT RESISTANCE OR MANIPULATION. THIS EMBOLIZED OBJECT REPRESENTS AN APPROXIMATELY 2.5 MM CIRCULAR, THIN METALLIC MARKER THAT WOULD BE NEAR IMPOSSIBLE TO RETRIEVE ENDOVASCULARLY IN THE PHYSICIAN'S OPINION. ADDITIONALLY, THE PATIENT WAS TACHYCARDIC, HYPOXIC, AND HAD SIGNIFICANT PULMONARY INJURY RELATED TO COVID. ANY ATTEMPT AT ENDOVASCULAR RETRIEVAL WOULD HAVE RESULTED IN MORE HARM TO THE PATIENT THAN RETAINING THE METALLIC MARKER. PATIENT IS ALSO NOT A CANDIDATE FOR OPEN SURGICAL RETRIEVAL OF THE MARKER. THIS TINY MARKER IS INCONSEQUENTIAL TO THE PATIENT'S PULMONARY FUNCTION PER PHYSICIAN'S OPINION. OUR REPRESENTATIVE WAS NOTIFIED OF THE EVENT AND CAME TO THE FACILITY TO TAKE PHOTOS OF THE SHEATH. THE DEVICE WAS NOT RELEASED TO THE REPRESENTATIVE AND AT THIS TIME STATUS REGARDING RELEASING IT IS PENDING. THE REPRESENTATIVE CAME TO THE FACILITY AND TOOK PHOTOS OF THE DEVICE. THE DEVICE WAS NOT RELEASED TO THE REPRESENTATIVE

  Patient problems: Foreign Body In Patient

  MAUDE report 12522939 ↗
• InjurySep 3, 2021Connection Problem; Patient Device Interaction Problem

  DISTAL RADIOPAQUE BAND CAME OFF THE DILATOR WHILE GETTING INSERTED INTO THE BODY, AND THE RADIOPAQUE BAND TRAVELED INTO THE RIGHT LUNGS¿ .

  Patient problems: Insufficient Information

  MAUDE report 12425404 ↗
• MalfunctionJul 21, 2021Activation, Positioning or Separation Problem

  WHEN DEPLOYING THE FILTER IT DID NOT OPEN ALL THE WAY AND HAD TO BE IMMEDIATELY RETRIEVED AFTER DEPLOYMENT WAS UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206340 ↗
• InjuryJun 3, 2021Malposition of Device

  ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION ELITE VENA CAVA FILTER ON OR ABOUT (B)(6) 2018 BY DR. (B)(6) AT MEDICAL CENTER HOSPITAL IN (B)(6). THE COMPLAINT ALLEGES THERE WAS TILT. THE FILTER WAS NOT RETRIEVED. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 11935538 ↗
• InjuryDec 16, 2020Break

  1 BARB BROKE OFF AND REMAINED EXTRAVASCULAR.

  Patient problems: Foreign Body In Patient

  MAUDE report 11020753 ↗
• InjuryOct 20, 2020Unintended Movement

  ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION ELITE VENA CAVA FILTER ON OR ABOUT (B)(6) 2017 BY DR. (B)(6). THE COMPLAINT ALLEGES THERE WAS EMBEDMENT AND TILT POST-IMPLANT. THE FILTER WAS NOT ABLE TO BE RETRIEVED. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10706460 ↗
• InjuryOct 12, 2020Unintended Movement

  ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION ELITE VENA CAVA FILTER ON OR ABOUT (B)(6) 2016 BY DR. (B)(6). THE COMPLAINT ALLEGES THERE WAS TILT POST-IMPLANT. THE FILTER WAS RETRIEVED. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 10667389 ↗
• InjuryOct 9, 2020Unintended Movement

  ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION ELITE VENA CAVA FILTER ON OR ABOUT (B)(6) 2018 BY DR. (B)(6). THE COMPLAINT ALLEGES THERE WAS EMBEDMENT AND TILT POST-IMPLANT. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10659502 ↗
• InjuryOct 1, 2020Migration

  ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION ELITE VENA CAVA FILTER ON OR ABOUT (B)(6) 2016 BY DR. (B)(6) AT (B)(6) UNIVERSITY MEDICAL CENTER IN (B)(6). THE COMPLAINT ALLEGES THERE WAS TILT AND PERFORATION POST-IMPLANT. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 10611446 ↗
• InjuryOct 1, 2020Migration or Expulsion of Device; Difficult to Remove; Positioning Problem

  ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION ELITE VENA CAVA FILTER ON OR ABOUT (B)(6) 2016 BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6). THE COMPLAINT ALLEGES THERE WAS BREAKTHROUGH PE, EMBEDMENT, TILT AND MIGRATION POST-IMPLANT. THE FILTER WAS UNABLE TO BE REMOVED FROM THE INFERIOR VENA CAVA. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

  Patient problems: Pulmonary Embolism

  MAUDE report 10611440 ↗
• InjuryOct 1, 2020Difficult to Remove; Positioning Problem

  ACCORDING TO THE NOTICE RECEIVED BY WAY OF A CIVIL ACTION COMPLAINT, THE PATIENT WAS PRESCRIBED AND IMPLANTED WITH AN OPTION ELITE VENA CAVA FILTER ON OR ABOUT (B)(6) 2019 BY DR. (B)(6). THE COMPLAINT ALLEGES THERE WAS EMBEDMENT AND TILT POST-IMPLANT. THE FILTER WAS UNABLE TO BE REMOVED FROM THE INFERIOR VENA CAVA. ARGON¿S ATTORNEYS ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 10611434 ↗