Denali® Vena Cava Filter DL900FRecalls & reported problems

Summary

The FDA's MAUDE database contains 529 adverse event reports that list this exact device (DI 00801741040801), received between Oct 21, 2015 and Sep 28, 2026 — classified as 22 deaths, 239 injuries, 268 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (171 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 25 most recent of 529 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Migration

  A patient underwent a percutaneous inferior vena cava (IVC) filter implantation procedure using a Denali Filter via femoral vein access. During the procedure, it was reported that the filter had allegedly migrated from its intended position. It was further reported that two attempts were made to retrieve the Denali Filter; however, the retrieval attempts were unsuccessful. Subsequently, another physician ordered an abdominal MRI for further evaluation. The patient's current status is unknown.

  Patient problems: Foreign Body In Patient

  MAUDE report 50910808 ↗
• MalfunctionAug 10, 2026Detachment of Device or Device Component

  On (b)(6) 2026, a patient underwent a percutaneous inferior vena cava filter implantation via the femoral vein using a Denali filter. During the procedure, the flushing port on the delivery sheath was allegedly detached. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191009 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. PRIOR TO THE PROCEDURE, IT WAS NOTICED THAT THE SIDE ARM FLUSH FELL OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389765 ↗
• MalfunctionMar 25, 2026Failure to Advance; Detachment of Device or Device Component

  ON (B)(6) 2025, PRIOR TO A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE FILTER ALLEGEDLY UNABLE TO ADVANCE THROUGH THE DEPLOYMENT SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686795 ↗
• MalfunctionMar 18, 2026Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION IN FEMORAL VEIN USING A DENALI FILTER. DURING THE PROCEDURE, IT WAS FOUND THAT THE SHEATH WAS ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631360 ↗
• MalfunctionFeb 3, 2026Malposition of Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. DURING THE PROCEDURE, THE SHEATH GRABBED THE FILTER AND ALLEGEDLY TURNS THE FILTER INTO SIDEWAY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244424 ↗
• MalfunctionJan 29, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION BY USING A DENALI FILTER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE FILTER TRANSDUCER PORT WAS ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207151 ↗
• InjuryDec 1, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2024, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. POST THE PROCEDURE ON (B)(6) 2025, DURING REMOVAL, THE FILTER PUNCTURED PATIENT'S HEART WHICH REQUIRED EMERGENCY CARDIO SURGERY/REPAIR AND TRANSPORT TO ANOTHER FACILITY. FURTHERMORE, THE HCP ATTEMPTED TO REMOVE THE DENALI IVC FILTER USING A BENSON WIRE. WHILE INTRODUCING AND ADVANCING THE SHEATH THROUGH THE IVC FILTER, THE SHEATH BUCKLED. THE HCP SUBSEQUENTLY REALIGNED THE SHEATH AND WAS ABLE TO SUCCESSFULLY RETRIEVE THE IVC FILTER. THE REPORTER RECANTED THE ALLEGATION OF DEVICE FAILURE, CONFIRMING THAT THE REPORTED ISSUE WAS ASSOCIATED WITH A NON-BD DEVICE.

  Patient problems: Perforation of Vessels

  MAUDE report 23678446 ↗
• MalfunctionNov 20, 2025Positioning Failure; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Positioning Failure; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  ON (B)(6) 2025, A 87-YEAR-OLD MALE PATIENT UNDERWENT AN INFERIOR VENA CAVA FILTER PLACEMENT PROCEDURE IN RIGHT FEMORAL GROIN VEIN FOR DEEP VEIN THROMBOSIS. DURING THE PROCEDURE THE FILTER ALLEGEDLY DID NOT DEPLOY 2X SAME PT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602912 ↗
• MalfunctionAug 4, 2025Premature Activation; Detachment of Device or Device Component; Premature Activation; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE Y-CONNECTION CAME APART AND WHEN DOING SO THE FILTER DEPLOYED PRE-MATURELY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22697533 ↗
• MalfunctionApr 28, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT AN INFERIOR VENA CAVA FILTER IMPLANTATION PROCEDURE USING DENALI FILTER. IT WAS REPORTED THAT THE DENALI FILTER ALLEGEDLY DID NOT OPEN WHEN DEPLOYED, FILTER MANUALLY OPEN WITH A BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916860 ↗
• InjuryJan 9, 2025Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA FILTER PLACEMENT PROCEDURE, THE FILTER HAD ALLEGEDLY MIGRATED THROUGH THE HEART TO THE PULMONARY ARTERY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21119614 ↗
• InjuryNov 1, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT WITH LOWER EXTREMITY DEEP VEIN THROMBOSIS AND PULMONARY EMBOLUS. IT WAS REPORTED THAT THE TWO YEARS, ONE MONTH AND TEN DAYS POST A FILTER DEPLOYMENT, IT WAS ALLEGED THAT FILTER STRUT DETACHED AND ALLEGEDLY DIFFICULT TO REMOVE THE FILTER. IT WAS FURTHER REPORTED THAT THE FILTER REMOVED AND NEW FILTER HAS BEEN PLACED. THE FRACTURED STRUT COMPLETELY BURIED WITHIN THE BRANCH OF THE HEPATIC VEIN. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 20586331 ↗
• MalfunctionJul 10, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A VENA CAVA FILTER PLACEMENT PROCEDURE VIA THE FEMORAL ARTERY, THE FILTER ALLEGEDLY WOULD NOT BE OPENED UP. IT WAS FURTHER REPORTED THE FILTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19708252 ↗
• InjuryMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT THREE YEARS, SEVEN MONTHS, AND TWENTY-ONE DAYS POST A VENA CAVA FILTER PLACEMENT VIA THE RIGHT COMMON FEMORAL VEIN, IT WAS ALLEGED THAT THE FILTER STRUT HAD DETACHED AND MIGRATED INTO THE PATIENT'S RIGHT VENTRICLE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED CHEST PAIN AND LATER DIED DUE TO COMPLICATIONS OF METASTATIC LUNG CANCER. HOWEVER, THE RELATIONSHIP OF THE DEATH WAS NOT RELATED TO THE DEVICE. REPORTEDLY, THE FILTER WAS REMOVED DURING AUTOPSY.

  Patient problems: Chest Pain; Insufficient Information

  MAUDE report 18957253 ↗
• MalfunctionFeb 9, 2024Difficult to Remove; Positioning Problem; Activation Failure; Difficult to Remove; Positioning Problem; Activation Failure

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED SUCCESSFULLY IN A PATIENT WITH DEEP VEIN THROMBOSIS. DURING DEPLOYMENT, IT WAS FOUND THAT THE FILTER WAS ALLEGEDLY DEPLOYED IN AN UNSATISFACTORY POSITION AND THE FILTER DID NOT OPEN WELL. IT WAS FURTHER REPORTED THAT THE FILTER WAS ALLEGEDLY NOT ABLE TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675098 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED SUCCESSFULLY, IN A PATIENT WITH RECURRENT PULMONARY EMBOLI. IT WAS FURTHER REPORTED THAT IN TEN MONTHS FIVE DAYS POST A FILTER DEPLOYMENT, PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS AND THROMBUS ABOVE THE FILTER. REPORTEDLY, THE DEVICE HAS BEEN REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18638310 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT THROUGH THE LEFT COMMON FEMORAL VEIN APPROACH, AN INFERIOR VENA CAVA FILTER WAS DEPLOYED IN A PATIENT AFTER BEING DIAGNOSED WITH CLOT EXTENDING FROM THE RIGHT FEMORAL VEIN TO THE LEVEL OF THE RIGHT EXTERNAL ILIAC VEIN. SIX DAYS POST THE FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE PATIENT ALLEGEDLY EXPERIENCED PULMONARY EMBOLISM. THE DEVICE HAS NOT BEEN REMOVED, AND THERE HAVE BEEN NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pulmonary Embolism

  MAUDE report 18481434 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIMES POST A VENA CAVA FILTER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION AND ARTHRITIC SORE IN THE LEG. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18361651 ↗
• InjuryDec 11, 2023Malposition of Device; Patient-Device Incompatibility; Malposition of Device; Patient-Device Incompatibility

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED VIA RIGHT COMMON FEMORAL VEIN APPROACH FOR A PATIENT WITH HIGH RISK FOR DEEP VEIN THROMBOSIS AND UNABLE TO ANTI-COAGULATE SECONDARY TO INTRACRANIAL BLEEDING. IT WAS FURTHER REPORTED THAT THREE YEARS, SIX MONTHS AND TWENTY-SIX DAYS POST FILTER DEPLOYMENT, THE FILTER WAS ALLEGEDLY TILTED ANTERIORLY WITH ITS CONE LYING ON THE POSTERIOR WALL OF THE INFERIOR VENA CAVA. FURTHERMORE, THE FILTER STRUTS HAD ALLEGEDLY PERFORATED THE INFERIOR VENA CAVA INTO THE PERICAVAL/MESENTERIC FAT AND ONE OF THE LEGS WAS IN CONTACT WITH THE ANTERIOR PERIOSTEUM OF A LUMBAR VERTEBRA. REPORTEDLY, THE PATIENT ALLEGEDLY EXPERIENCED HIP PAIN. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 18299239 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED SUCCESSFULLY IN A PATIENT AFTER BEING DIAGNOSED WITH PULMONARY EMBOLISM AND HYPERCOAGULABLE STATE. SIX MONTHS AND SIX DAYS POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE PATIENT WAS DIAGNOSED WITH THROMBUS ABOVE THE INFERIOR VENA CAVA FILTER. REPORTEDLY, THE FILTER HAS BEEN REMOVED WITH A SNARE DEVICE UNDER FLUOROSCOPY. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18147184 ↗
• MalfunctionOct 20, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PRIOR TO A VENA CAVA FILTER PLACEMENT PROCEDURE, UPON OPENING THE PACKAGE, THE FILTER WAS ALLEGEDLY PREDEPLOYED PARTIALLY INTO THE SHEATH. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17972279 ↗
• MalfunctionOct 4, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF A VENA CAVA FILTER PLACEMENT PROCEDURE, THE FILTER WAS ALLEGEDLY DETACHED IN THE INTRODUCER SHEATH AND REMAINED IN THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17866681 ↗
• InjurySep 8, 2023Difficult to Remove; Obstruction of Flow; Migration; Difficult to Remove; Obstruction of Flow; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH PULMONARY EMBOLISM AND A HYPERCOAGULABLE STATE OF MALIGNANCY. APPROXIMATELY TWO YEARS AND EIGHT MONTHS POST FILTER DEPLOYMENT, SUBSEQUENT IMAGING DEMONSTRATED OCCLUSION OF THE FILTER, AND THE PATIENT ALLEGEDLY EXPERIENCED THROMBOSIS, WHICH REQUIRED THROMBOLYSIS. IT WAS FURTHER REPORTED THAT THE FILTER HAD ALLEGEDLY MIGRATED. REPORTEDLY, THE DEVICE HAS BEEN REMOVED PERCUTANEOUSLY AFTER UNSUCCESSFUL ATTEMPTS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17708890 ↗
• MalfunctionSep 6, 2023Difficult to Remove; Malposition of Device; Patient-Device Incompatibility; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Malposition of Device; Patient-Device Incompatibility; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH PULMONARY THROMBOEMBOLISM. SIX MONTHS AND TEN DAYS POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER HAD DETACHED, MATERIAL DEFORMED, PERFORATED, AND THE FILTER TILTED. THE DEVICE HAS NOT BEEN REMOVED AFTER AN ATTEMPTED BUT UNSUCCESSFUL PERCUTANEOUS REMOVAL PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689456 ↗