VENA TECH 5010028Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04027478130752), received between Aug 9, 2016 and Feb 19, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2025Activation Failure; Activation Failure

  "CONVERTIBLE IVC FILTER WAS PLACED BUT DID NOT SELF EXPAND. DR (B)(6) WAS ABLE TO GET A CATHETER THROUGH THE FILTER AND INFLATE A BALLOON TO GET THE FILTER TO EXPAND. HE HAD TO ASSIST SEVERAL DIFFERENT SIDES BEFORE FULL EXPANSION WAS ACHIEVED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412565 ↗
• MalfunctionJan 18, 2022Activation Failure; Activation Failure

  THE FILTER WAS CAUGHT ON THE END OF THE SHEATH DURING DEPLOYMENT. AS A RESULT, A FEW OF THE LEGS MISDEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282402 ↗
• MalfunctionNov 25, 2020Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Material Twisted/Bent; Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  UPON PLACEMENT, THE FILTER DID NOT OPEN AND ONE LEG IS EXTENDING OUTSIDE THE FILTER PROFILE. PRE-PLACEMENT CAVOGRAM IS NOT AVAILABLE FOR REVIEW. THE FINAL FILM TAKEN AFTER IMPLANTATION IS AVAILABLE. THE INDICATION FOR FILTER IMPLANTATION IS UNKNOWN. THE APPROACH WAS JUGULAR. THE DIAMETER OF THE VENA CAVA BEFORE IMPLANTATION IS UNKNOWN. A SECOND FILTER WAS NOT USED TO COMPLETE THE PROCEDURE. PHYSICIAN REPORTS THAT THE PATIENT IS VERY ILL AND THE ACCOUNT DOES NOT EXPECT ANY FURTHER INTERVENTION REGARDING THIS FILTER. THERE WAS NO PRESSURE FELT OR CATCHING OF THE HOOKS IN THE DISTAL PORTION OF THE SHEATH. VERY FLAT IVC AND THE FELLOW DEPLOYED IT PROBABLY BY PUSHING IT FORWARD, SO IT CAUGHT ON THE WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10906179 ↗
• InjuryJun 16, 2020Difficult to Fold, Unfold or Collapse; Migration; Difficult to Fold, Unfold or Collapse; Migration

  WHEN DEPLOYING THE CONVERTIBLE FILTER, A STABILIZING LEG GOT CAUGHT IN THE SHEATH AND THE FILTER ENDED UP IN THE JUNCTION BETWEEN THE RIGHT ATRIUM AND THE SVC. THE PATIENT SUFFERED NO CLINICAL ADVERSE EVENT FROM THE DEPLOYMENT AND A VENATECH LP FILTER WAS PLACED FROM THE FEMORAL APPROACH WITHOUT INCIDENT. PLACED VIA THE JUGULAR APPROACH. FILTER LOCATION: SUPRA-RENAL. THE PATIENT HAS NOT UNDERGONE SURGERY SINCE THE FILTER PLACEMENT. TIME FRAME OF EVENT: DURING IMPLANT. THE PATIENT SUFFERED NO ADVERSE CLINICAL EVENT WHERE THE CONVERTIBLE FILTER IS LODGED. THE PATIENT IS FINE AS DESCRIBED BY PHYSICIAN. UPDATED INFORMATION: INDICATION FOR FILTER PLACEMENT: PE WHEN ANTICOAGULANT IS CONTRAINDICATED. THERE WAS A CENTRAL LINE IN PLACE WHEN THE FILTER WAS IMPLANTED. DEPLOYMENT LEVEL: THE CONVERTIBLE FILTER WAS DEPLOYED IN THE CORRECT PLACE (BELOW THE RENAL VEINS) BUT THE FILTER WAS PULLED BY THE SHEATH (WHEN THE SHEATH WAS REMOVED). WHILE THE SHEATH WAS BEING REMOVED, A FILTER LEG WAS CAUGHT IN THE SHEATH. THEN THE PHYSICIAN PULLED THE FILTER AND SHEATH BACK AND THE FILTER RELEASED FROM THE SHEATH. THE PHYSICIAN SNARED THE FILTER TO GET IT PART WAY OUT OF THE HEART.

  Patient problems: Foreign Body In Patient

  MAUDE report 10158491 ↗
• MalfunctionMay 18, 2020Activation, Positioning or Separation Problem

  FILTER DEPLOYED IN RIGHT ATRIUM; THE IVC FILTER WAS DEPLOYED USING THE PLUNGER DEVICE IN THE KIT BUT A HOOK OF THE FILTER HUNG ON THE SHEATH. WHILE THE SHEATH WAS REMOVED FROM THE INFERIOR VENA CAVA, THE FILTER MOVED WITH THE SHEATH AND DEPLOYED IN THE RIGHT ATRIUM FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10069742 ↗
• MalfunctionSep 7, 2018Difficult to Open or Close; Difficult to Open or Close

  SIGNIFICANT RESISTANCE UPON IMPLANTING OF FILTER, RESULT WAS LEG CROSSING FULLY. RESISTANCE MID TO DISTAL SHEATH WHILE GOING THROUGH MASS OF IVC. RESISTANCE FELT MORE SO THAN TYPICAL. ON (B)(6) 2018 - IN A FAX FROM THE ACCOUNT: THE FILTER WAS DEPLOYED BUT WAS DISTORTED. AT LEAST ONE LEG WAS OFFSET. INDICATION FOR IMPLANTATION: PULMONARY THROMBOEMBOLISM WHEN ANTICOAGULANTS ARE CONTRAINDICATED. THE APPROACH WAS JUGULAR. DIAMETER OF THE VENA CAVA BEFORE IMPLANTATION: 18MM. THE PATIENT DID NOT HAVE A CENTRAL VENOUS CATHETER PLACED BEFORE FILTER PLACEMENT. FILTER LOCATION: INFRA-RENAL. DEPLOYMENT LEVEL: L3. THE PATIENT HAS NOT UNDERGONE SURGERY SINCE THE FILTER PLACEMENT. PATIENT CO-MORBIDITIES: OVARIAN CANCER. TIMEFRAME OF EVENT: DURING IMPLANT. CIRCUMSTANCES UNDER WHICH THE PIR INCIDENT WAS DISCOVERED: IMMEDIATELY AFTER IMPLANTATION/DEPLOYMENT. PATIENT HAD NO SYMPTOMS. NO ADVERSE EVENT WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7855324 ↗
• MalfunctionSep 7, 2018Difficult to Open or Close; Difficult to Open or Close

  SIGNIFICANT RESISTANCE UPON IMPLANTING OF FILTER, RESULT WAS LEG CROSSING FULLY. RESISTANCE MID TO DISTAL SHEATH WHILE GOING THROUGH MASS OF IVC. RESISTANCE FELT MORE SO THAN TYPICAL. PHYSICIAN NOTED THAT IT FELT LIKE IT WAS STUCK ON SOMETHING IN THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7855320 ↗
• MalfunctionMay 3, 2017Improper or Incorrect Procedure or Method; Misassembly by Users; Improper or Incorrect Procedure or Method; Misassembly by Users

  AFTER A VENACAVAGRAM WAS COMPLETED, THE CONVERTIBLE FILTER WAS DEPLOYED VIA THE LEFT FEMORAL VEIN. AFTER DEPLOYMENT, FLUOROSCOPY SHOWED THE CONVERTIBLE FILTER TO BE UPSIDE DOWN. THE PHYSICIAN THEN DEPLOYED A LP FILTER VIA THE LEFT FEMORAL VEIN THROUGH THE CONVERTIBLE SHEATH. PLACEMENT OF THE LP FILTER WAS ABOVE THE CONVERTIBLE FILTER. PHYSICIAN WAS POSITIONED AT THE TABLE ON THE LEFT SIDE OF THE PATIENT FOR THE DURATION OF THE CASE. FILTER LOCATION: INFRARENAL. INDICATION FOR FILTER IMPLANTATION: SUSPECTED DVT IN LOWER RIGHT LEG. TIME FRAME OF EVENT: DURING IMPLANT. NO ADVERSE EVENT NOTED. ACCOUNT CONFIRMED THAT THE CARTRIDGE WAS IN THE INCORRECT ORIENTATION FOR IMPLANTATION. DR. ARTS SUCCESSFULLY CONVERTED THE CONVERTIBLE FILTER ON (B)(6) 2017 FROM THE RIGHT FEMORAL APPROACH USING SOS OMNI-FLUSH, 20MM AMPLAZTZ GOOSENECK SNARE. CAVA WAS OPEN. PT WAS RELEASED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6539873 ↗
• InjuryFeb 23, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PLACEMENT OF A CONVERTIBLE FILTER IN THE PRESENCE OF RIGHT LOWER-EXTREMITY DEEP VEIN THROMBOSIS TO PREVENT PULMONARY EMBOLISM. THE FILTER WAS IMPLANTED AT AN UNKNOWN HOSPITAL. NINETEEN DAYS LATER, PATIENT WAS REFERRED FOR THE DISCONTINUATION OF IVC FILTRATION. RIGHT INTERNAL JUGULAR VEIN ACCESS WAS OBTAINED, AN 18-30 MM ENSNARE ENDOVASCULAR SNARE WAS ADVANCED TO THE FILTER. THE FILTER HEAD WAS GRASPED WITH THE SNARE AND DETACHED FROM THE LEGS OF THE FILTER, RESULTING IN A 180 DEGREE TURN SUCH THAT THE HOOK OF THE FILTER HEAD WAS LATCHED ONTO THE OPENING OF THE SHEATH, WITH THE REMAINDER OF THE FILTER HEAD RESIDING OUTSIDE THE SHEATH. DURING THE PROCESS OF OBTAINING FEMORAL ACCESS, THE FILTER HEAD DISLODGED FROM THE EDGE OF THE SHEATH AND EMBOLIZED TO A BRANCH OF THE LEFT LOWER-LOBE PULMONARY ARTERY. A 9-15 MM ENSNARE ENDOVASCULAR SNARE WAS ADVANCED FROM THE FEMORAL ACCESS SITE, AND THE FILTER HEAD WAS SNARED AND REMOVED FROM THE PATIENT. THE POSTPROCEDURAL COURSE WAS UNREMARKABLE, AND THE PATIENT CONTINUED TO RECEIVE LONG-TERM ANTICOAGULATION FOR DEEP VEIN THROMBOSIS AS DIRECTED BY THE PRIMARY CLINICAL TEAM.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6352063 ↗
• InjuryAug 9, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  RIGHT IJ PUNCTURE SITE. CO2 VENACAVAGRAM, AND SUBSEQUENT INTRODUCTION OF THE CONVERTIBLE INTRODUCER. FILTER WAS INSERTED INTO THE SHEATH, PUSHER WAS THEN REMOVED, FILTER CARTRIDGE WAS REMOVED, SHEATH WAS FLUSH WITH HEPARINIZED SALINE, THE PUSHER WAS REINTRODUCED, AND THE FILTER DEPLOYED. THE FILER WAS NOTED TO NOT OPEN ON THE DISTAL (BOTTOM) END WHILE THE CONE AND TOP OF THE STABILIZING LEGS WERE OPENED. THE PHYSICIAN THEN "SHOOK THE FILTER WITH THE END OF THE SHEATH", WHICH DID NOT OPEN THE BASE OF THE FILTER. HE THEN NOTED THAT THE FILTER WAS MIGRATING IN THE PARTIALLY OPENED CONFIGURATION FROM THE IVC TO THE PATIENT'S HEART. THE PHYSICIAN WAS ABLE TO SNARE THE CONVERTIBLE FROM BELOW THE FILTER HEAR THROUGH A 16 FR SHEATH, BUT WAS UNABLE TO SNARE THE DISTAL END OF THE FILTER. THE FILTER WAS REMOVED WITHOUT INCIDENT VIA THE RIJ.

  Patient problems: No Code Available

  MAUDE report 5856973 ↗