Option Elite Retrievable Vena Cava Filter System 352506070ERecalls & reported problems

Summary

The FDA's MAUDE database contains 342 adverse event reports that list this exact device (DI 00886333217151), received between Mar 25, 2020 and Sep 30, 2026 — classified as 3 deaths, 164 injuries, 175 malfunctions.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (44 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Sep 12, 2025Class IIOpen, Classified

   Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied

   Z-0589-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗

2. Jun 8, 2023Class IIOpen, Classified

   There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.

   Z-2239-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 342 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Unfold or Unwrap

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951316 ↗
• InjurySep 11, 2026Detachment of Device or Device Component

  DISTAL RADIOPAQUE MARKER BAND OF THE ARGON OPTION ELITE FILTER DELIVERY SET DILATOR APPEARS TO HAVE SLIPPED OFF DURING DILATOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50737070 ↗
• MalfunctionAug 14, 2026Failure to Unfold or Unwrap

  Patient problems: Insufficient Information

  MAUDE report 50257893 ↗
• InjuryJul 29, 2026Detachment of Device or Device Component

  Customer reported during IVC filter placement, the physician encountered difficulty removing the dilator from the sheath. When he pulled again on the dilator, it came out but the radiopaque markers were not on the dilator. Fluoroscopy showed one marker left behind in the patient. The physician was able to remove the marker from the patient. They opened a different kit and completed the procedure successfully. Only the dilator is available for return. Additional information has been requested.

  Patient problems: Foreign Body In Patient

  MAUDE report 50075572 ↗
• InjuryMay 9, 2026Failure to Unfold or Unwrap

  THE FILTER WAS PLACED UPSIDE DOWN IN THE STORAGE CHAMBER.

  Patient problems: Insufficient Information

  MAUDE report 25132816 ↗
• MalfunctionMay 9, 2026Failure to Unfold or Unwrap

  REPORTER STATED "THE FILTER IS NOT FULLY OPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25132801 ↗
• MalfunctionApr 30, 2026Failure to Unfold or Unwrap

  WHEN THE FILTER WAS RELEASED, IT REACHED THE ESTABLISHED POSITION, AND THE ANCHOR FOOT OF THE FILTER DID NOT DEPLOY, RESULTING IN FAILURE TO FIX IT IN THE INFERIOR VENA CAVA, RESULTING IN FAILURE OF THE OPERATION. THEREFORE, THE OPERATOR USED A SNARE TO REMOVE THE UNDEPLOYED FILTER AND PERFORMED THE REMAINING PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046573 ↗
• InjuryMar 30, 2026Failure to Unfold or Unwrap

  REPORTER STATED "DURING A PROCEDURE ON (B)(6) 2026, PERFORMED VIA FEMORAL ACCESS, THE FILTER LEGS FAILED TO EXPAND NORMALLY AND BECAME ENTANGLED WITH ONE ANOTHER. THIS MALFUNCTION PLACED THE PATIENT AT IMMEDIATE RISK OF FILTER MIGRATION TO THE HEART, REPRESENTING A CRITICAL AND POTENTIALLY FATAL SITUATION. TO ENSURE PATIENT SAFETY, WE OBTAINED JUGULAR ACCESS, SUCCESSFULLY SNARED AND RETRIEVED THE MALFUNCTIONING FILTER, AND SUBSEQUENTLY PLACED A REPLACEMENT FILTER, WHICH DEPLOYED SAFELY WITHOUT COMPLICATIONS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24721830 ↗
• MalfunctionMar 30, 2026Defective Component

  AFTER THE SURGEON RELEASED IT INSIDE THE BODY, THE IMAGING SHOWED A CLEAR ADHESION. HOWEVER, WHEN IT WAS REMOVED IMMEDIATELY, IT WAS FOUND THAT ONE OF THE ANCHOR LEGS OF THE FILTER HAD A SIGNIFICANT DEVIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24721640 ↗
• InjuryMar 30, 2026Failure to Unfold or Unwrap

  WHEN THE FILTER WAS RELEASED, IT FAILED TO OPEN PROPERLY, CAUSING THE FILTER TO MOVE ALONG THE BLOOD VESSEL INTO THE ATRIUM.

  Patient problems: Insufficient Information

  MAUDE report 24708640 ↗
• MalfunctionMar 7, 2026Failure to Unfold or Unwrap

  DURING THE OPERATION, THE FILTER FAILED TO OPEN PROPERLY AFTER BEING RELEASED. MEDICAL INTERVENTION - THE UNOPENED FILTER NEEDS TO BE REMOVED FIRST, AND THEN A NEW FILTER SHOULD BE PLACED IN ITS PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24540686 ↗
• MalfunctionFeb 14, 2026Misassembled

  AFTER THE FILTER WAS REMOVED, IT WAS FOUND THAT THE DIRECTION WAS INCORRECT. THE FILTER WAS RETRIEVED THROUGH THE FEMORAL VEIN AND A NEW ONE WAS RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340968 ↗
• InjuryFeb 13, 2026Fracture

  BARIATRIC PATIENT HAD A FILTER PLACED IN 2016. FILTER FRACTURED AND IMAGING FROM 2022 SHOWED A PIECE ACCORDING TO THE PHYSICIAN, LOCATED IN THE AORTA.

  Patient problems: Insufficient Information

  MAUDE report 24339192 ↗
• InjuryFeb 11, 2026Failure to Unfold or Unwrap

  AFTER BEING IMPLANTED INTO THE PATIENT'S BODY, THE FILTER WAS NOT OPENED. LATER, IT WAS OPENED AFTER ADJUSTMENTS, BUT IT WAS SEVERELY TILTED AND COULD NOT EFFECTIVELY INTERCEPT BLOOD CLOTS. DSA SHOWED LARGE BLOOD CLOTS PASSING THROUGH THE FILTER. THE SURGEON THEN RETRIEVED THE FILTER AND REPLACED IT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319169 ↗
• MalfunctionJan 29, 2026Failure to Unfold or Unwrap

  REPORTER STATED THE FILTER DEVICE DID NOT FULLY OPEN AFTER BEING RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217545 ↗
• MalfunctionJan 9, 2026Detachment of Device or Device Component

  A REPORT RECEIVED VIA MEDWATCH STATED "THE SHEATH HAD ALREADY BEEN INTRODUCED INTO THE PATIENT'S RIGHT FEMORAL VEIN BEFORE IT WAS EVIDENCED BY FLUORSCOPY THAT THE DISTAL MARKER WAS NOT PRESENT. THE LOCATION OF THE SHEATH TIP WAS EVIDENCED BY HIGHER-LEVEL IMAGING BEFORE THE FILTER WAS SUCCESSFULLLY DEPLOYED. AFTER THE CASE, I EXAMINED THE EQUIPMENT USED (USING FLUOROSCOPY) AND FOUND THE MISSING MARKER - IT WAS AT THE PROXIMAL END, INSTEAD OF THE DISTAL END OF THE SHEATH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022795 ↗
• MalfunctionJan 6, 2026Failure to Unfold or Unwrap

  REPORTER STATED AFTER DEPLOYING AN IVC FILTER (NOT OVER THE WIRE) AND THE LEGS DID NOT OPEN. THE FILTER WAS FLOATING IN THE IVC. TRIED TO OPEN THE LEGS WITH A CATHETER/WIRE, BUT IT DIDN¿T WORK AND THE FILTER TILTED SO IT WAS DECIDED TO REMOVE IT AND PLACE A NEW ONE. WHEN TRYING TO RETRIEVE THE FILTER, THE LEGS OPENED BUT THE FILTER WAS SUPRARENAL AT THAT POINT. DURING THE RETRIEVAL, THE LEGS WOULD NOT COLLAPSE. ONE OF THEM EVEN BENT AND FOLDED ON ITS OWN COMPLETELY. FINALLY, THE DOCTOR WAS ABLE TO MANIPULATE AND RETRIEVE. A NEW OPTION FILTER WAS PLACED WITHOUT ISSUE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. DEVICE IS AVAILABLE TO SEND BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986284 ↗
• MalfunctionDec 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  A DOCTOR WAS PLACING AN OPTION FILTER INTO A PATIENT WITH SOME SCARING AND THICKER THAN AVERAGE VEIN CALCIFICATION. THE SITE WAS PRE DILATED WITH A 6FR SHEATH AND THEN OPTION WAS PLACED OVER A GUIDEWIRE WITHOUT ISSUE. VENOGRAM WAS PERFORMED AND OPTION WAS PLACED VIA THE PUSHER WITHOUT INCIDENT. WHEN REMOVING THE SHEATH THERE WAS SIGNIFICANT RESISTANCE AND RECOILING. THE DOCTOR MOVED CLOSER TO THE INSERTION SITE AND ATTEMPTED TO REMOVE THE SHEATH AGAIN AND THE SHEATH UNDER TENSION CAME OUT BUT UPON EXAMINATION THE TIP OF THE SHEATH BECAME DISLODGE AND THE COIL OF THE SHEATH WAS SEEN AT THE DISTAL END. IMAGINING WAS PERFORMED THAT SHOWED A R/O BAND IN THE PATIENT. ATTEMPTS WERE MADE AT A CUTDOWN BY ATTENDING DOCTOR, BUT WERE UNABLE TO SEE OR GET TO THE PIECE OF SHEATH. PATIENT WAS SENT FOR A CT SCAN AND THE MARKER BAND WAS SEEN WITHIN THE VENOUS VESSEL WALL BUT HAD NOT MOVED. DECISION WAS MADE TO LEAVE THE MATERIAL IN THE PATIENT AND PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857275 ↗
• InjuryDec 12, 2025Premature Activation; Premature Activation

  A STOMER REPORTED VIA MEDWATCH. "PATIENT WAS ORDERED TO HAVE A IVC FILTER PLACED. RIGHT GROIN WAS ACCESSED AND CATHETER POSITIONED IN IVC. UPON DEPLOYMENT OF THE IVC FILTER IT DEPLOYED PREMATURELY IN THE CATHETER AND WAS LODGED IN THE CATHETER. THE DEPLOYED DEVICE WAS REMOVED FROM THE RIGHT GROIN LOSING ACCESS. AFTER PRESSURE WAS HELD TO RIGHT GROIN THE LEFT GROIN WAS ACCESSED AND A IVC FILTER WAS DEPLOYED TO THE IVC WITHOUT ISSUE."

  Patient problems: Insufficient Information

  MAUDE report 23791697 ↗
• MalfunctionDec 2, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  THE REPORTER INDICATED "DURING IVC FILTER PROCEDURE, THE LEGS OF THE FILTER WERE NOT OPENING AFTER DEPLOYMENT, ALL LEGS WERE ATTACHED TO EACH OTHER, & SOME GLUE-LIKE SUBSTANCE ADHERING TO THE LEGS WERE NOT ALLOWING THE LEGS TO OPEN UP, THEN DR NEEDS TO RETRIEVE THE FILTER, & USED ANOTHER NEW FILTER IN THE SAME CASE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693370 ↗
• InjuryNov 13, 2025Break; Migration; Break; Migration

  SITUATION AN INFERIOR VENACAVA (IVC) FILTER HAD A RETENTION BARB AT THE TIP OF ONE OF THE FILTER LEGS SHEAR OFF DURING EXPLANT FROM A PATIENT. BARB REMAINED IN PATIENT AS A RETAINED FOREIGN BODY POST PROCEDURE. BACKGROUND PATIENT HAD AN IVC FILER PLACED BY (B)(6) BACK IN (B)(6) 2024 FOR LLE DEEP VEIN THROMBOSIS (DVT) & BILATERAL PULMONARY EMBOLISM (BILAT PE). PATIENT RETURNED TO (B)(6) FOR REMOVAL BUT, DUE TO THE POSITIONING OF THE FILTER AGAINST THE INFERIOR VENACAVA, (B)(6) UNABLE TO REMOVE. PATIENT SEEN BY OUR MEDICAL DOCTOR (MD) AND SCHEDULED FOR IVC REMOVAL AT ECH. DURING THE EXPLANT OF THE IVC FILTER, ONE OF THE RETENTION BARBS LOCATED AT THE DISTAL END OF THE IVC LEGS SHEARED OFF. UNDER FLUOROSCOPY, THE MD WAS ABLE TO DETERMINE THAT THE FOREIGN BODY HAD MIGRATED TO THE PULMONARY ARTERY. ASSESSMENT NO HARM TO THE PATIENT NOTED. IVC FILTER WAS SEQUESTERED BY VENDOR REP. MANUFACTURER WAS NOTIFIED AND THEY WILL BE COMMUNICATING WITH QUALITY/RISK ABOUT THE INCIDENT. RECOMMENDATION FROM A PROCEDURAL PERSPECTIVE, THIS IS AN UNPLANNED EVENT WITH A RETAINED FOREIGN BODY DUE TO A POTENTIAL DEFECT IN THE IMPLANT. WE DID NOTE POST PROCEDURE DEVIATIONS BY BOTH THE PROVIDER AND STAFF THAT

  Patient problems: Foreign Body In Patient

  MAUDE report 23551121 ↗
• MalfunctionNov 7, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NURSE MANAGER REPORTED "FEMORAL ACCESS, RESISTANCE MET WHEN INTRODUCING THE PUSHER WIRE INTO THE CARTRIDGE TO DEPLOY THE FILTER THROUGH THE DELIVERY SHEATH, THE FILTER DID NOT COMPLETELY DEPLOY OR OPEN, WAS PULLED BACK TO THE INSERTION SITE, THE FILTER DEPLOYED AT THIS LOCATION IN THE ILIAC VEIN, IT WAS THEN RETRIEVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498251 ↗
• InjuryOct 22, 2025Break; Break

  THE PHYSICIAN DEPLOYED THE FILTER OVER THE WIRE (OTW) VIA THE FEMORAL ACCESS. THE FILTER WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE MOST DISTAL RO BAND ON THE DILATOR CAME OFF THE DILATOR AND ENDED UP IN THE PATIENT'S IVC. THE FLOUORO IMAGES WILL BE PROVIDED, BUT HOSPITAL RISK TEAM WILL KEEP DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23359118 ↗
• MalfunctionOct 20, 2025Misassembled; Misassembled

  THE TECH AND PHYSICIAN VERIFIED, BOTH VISUALLY AND AUDIBLY, THE CARTRIDGE WAS BEING PLACED IN THE PROPER DIRECTION (JUGULAR ARROW INTO THE JUGULAR ACCESS). HOWEVER, THE FILTER WAS IN THE CARTRIDGE BACKWARDS AND DID NOT DEPLOY IN THE CORRECT ORIENTATION. THE FILTER WAS RETRIEVED. A NEW OPTION ELITE FROM THE SAME LOT WAS OPENED AND USED WITH NO ISSUES. THERE ARE NO FLUORO IMAGES AVAILABLE AT THIS TIME. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343759 ↗
• InjuryOct 15, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  ON (B)(6) 2025, THE CATHETERIZATION ROOM OF THE (B)(6) HOSPITAL OF (B)(6), PERFORMED A PROCEDURE OF IMPLANTING A VENA CAVA FILTER. DURING THE OPERATION, THE SURGEON USED THE OTW TECHNIQUE TO RELEASE THE FILTER, BUT THE ANCHOR FOOT COULD NOT OPEN AND WAS TIGHTLY BOUND TOGETHER. AFTER MULTIPLE ATTEMPTS, IT STILL COULD NOT BE RELEASED. THE SURGEON HAD NO CHOICE BUT TO USE AN ADDITIONAL CERVICAL RETRIEVAL LOOP DEVICE TO RETRIEVE THE FILTER. FINALLY, THE FILTER WAS SUCCESSFULLY RETRIEVED AND IT WAS FOUND THAT THE GUIDE WIRE IN THE ARC-SHAPED PUSHER WAS IN A SCREW-LIKE CURLED STATE, HOOKING ONTO THE ANCHOR FOOT OF THE FILTER. THE SURGEON THEN USED A NEW SECOND FILTER AND SUCCESSFULLY IMPLANTED IT. THIS INCIDENT WAS REPORTED BY THE SURGEON AS A HOSPITAL ADVERSE EVENT. IN THE FINAL SURGERY, TWO FILTERS AND AN ADDITIONAL FOREIGN BODY RETRIEVAL LOOP DEVICE WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285424 ↗