DENALI® Vena Cava Filter DL900JRecalls & reported problems
Bard Peripheral Vascular, Inc. · DENALI® Vena Cava Filter Jugular/Subclavian · Class 2 · Implant
Quick summary
This Bard Denali vena cava filter is a small implant placed in a large vein to catch blood clots. Many of its 490 reports describe filters that were misplaced, hard to remove or did not open properly. Some mention pulmonary embolism, a blood clot in the lungs. The reports include 151 injuries and 15 deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 492
- Deaths reported
- 15
- Injuries reported
- 152
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 492 adverse event reports that list this exact device (DI 00801741040795), received between Oct 21, 2014 and Sep 10, 2026 — classified as 15 deaths, 152 injuries, 325 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (121 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.
Reports received per month
Most reported problems
Device problems
- Malposition of Device121
- Difficult to Remove104
- Activation Failure86
- Patient Device Interaction Problem82
- Detachment of Device or Device Component71
- Patient-Device Incompatibility61
- Migration or Expulsion of Device40
- Adverse Event Without Identified Device or Use Problem39
Patient problems
- No Clinical Signs, Symptoms or Conditions184
- No Consequences Or Impact To Patient163
- Pulmonary Embolism52
- Abdominal Pain39
- Thrombus29
- Thrombosis/Thrombus20
- Pain15
- No Known Impact Or Consequence To Patient14
Recent adverse event reports
The 25 most recent of 492 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Detachment of Device or Device Component; Unintended Movement
On (b)(6) 2026, a patient underwent a percutaneous inferior vena cava filter implantation using a Denali filter. On (b)(6) 2026, the imaging revealed that one filter arm had fractured into two fragments, with one fragment migrating to the right renal vein and the other embedded in the IVC wall. The migrated fragment was associated with thrombus formation. On (b)(6) 2026, Balloon venoplasty and a sweeping technique were performed, removing most of the thrombus burden and filter. Follow up CT imaging confirmed that the small residual thrombus was not hemodynamically significant. The patient was discharged and no reported injury.
Patient problems: Foreign Body In Patient; Thrombosis/Thrombus
MAUDE report 50714881 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
A patient underwent a percutaneous inferior vena cava filter implantation via the jugular vein using a Denali filter. During the procedure, it was reported that the filter allegedly fractured without the application of excessive force and prior to being fully utilized as intended. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563563 ↗MalfunctionAug 3, 2026Premature Activation
On (b)(6) 2026, a patient underwent a percutaneous inferior vena cava filter implantation via the jugular vein using a Denali filter. During the procedure, the filter was allegedly deployed prematurely. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114814 ↗MalfunctionJun 18, 2026Activation Failure
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION IN JUGULAR VEIN USING A DENALI FILTER. DURING THE PROCEDURE, A DENALI FILTER EXPERIENCED INCOMPLETE EXPANSION BECAUSE TWO OF ITS LEGS WERE CROSSED, PREVENTING PROPER DEPLOYMENT OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25546124 ↗MalfunctionApr 17, 2026Break; Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. PRIOR TO THE PROCEDURE, THE HUB ON THE SHEATH WAS BROKEN OFF IN THE PLASTIC WHEN THE PACKAGE WAS OPENED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24907493 ↗MalfunctionMar 23, 2026Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION IN JUGULAR VEIN BY USING A DENALI FILTER. DURING THE PROCEDURE, SHEATH WAS ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660014 ↗MalfunctionMar 11, 2026Detachment of Device or Device Component
ON (B)(6), 2026, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. DURING THE PROCEDURE, THE SIDEARMS ON THE SHEATH DETACHED. THE PROCEDURE WAS COMPLETED USING THE SAME DEFECTIVE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567029 ↗MalfunctionMar 9, 2026Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION IN JUGULAR VEIN USING A DENALI FILTER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE FLUSH PORT ALLEGEDLY BECAME DETACHED WHILE FLUSHING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24543638 ↗MalfunctionMar 2, 2026
THE SIDE ARM DETACHED FROM THE SHEATH AFTER THE FILTER WAS DEPLOYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24477933 ↗MalfunctionFeb 27, 2026Positioning Problem; Activation Failure
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION IN JUGULAR VEIN BY USING A DENALI FILTER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE FILTER WAS ALLEGEDLY UNABLE TO PLACE CORRECTLY, AND FILTER LEGS WERE UNABLE TO EXPAND FULLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24466193 ↗MalfunctionFeb 19, 2026Premature Activation; Deformation Due to Compressive Stress
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION IN JUGULAR VEIN USING A DENALI FILTER. DURING THE PROCEDURE, FILTER ALLEGEDLY DEPLOYED PREMATURELY IN THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385548 ↗MalfunctionFeb 13, 2026Premature Activation; Material Twisted/Bent
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION IN JUGULAR VEIN USING A DENALI FILTER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE FILTER HAS DEPLOYED PREMATURELY BEFORE ADVANCING INTO SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24339865 ↗MalfunctionJan 5, 2026Activation Failure
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING THE DENALI FILTER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE FILTER WAS DEPLOYED BUT THE LEGS GOT TANGLED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23955055 ↗MalfunctionJan 5, 2026Premature Activation
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. DURING THE PROCEDURE, THE FILTER ALLEGEDLY DEPLOYED PREMATURELY INSIDE THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23954734 ↗MalfunctionNov 17, 2025Failure to Advance; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Failure to Advance; Deformation Due to Compressive Stress; Detachment of Device or Device Component
ON (B)(6) 2025, PRIOR TO AN PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION PROCEDURE USING THE DENALI FILTER, THE SHEATH WAS FAULTY AND THE FILTER ALLEGEDLY COULD NOT LOAD IN PROPERLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY. FURTHER, DETACHMENT AND DEFORMATION WAS RECORDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23567809 ↗MalfunctionNov 12, 2025Break; Detachment of Device or Device Component; Break; 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, THE FILTER WAS ALLEGEDLY TWISTED AND BROKE OFF, AND THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING. CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 23530480 ↗MalfunctionNov 10, 2025Activation Failure; Activation Failure
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. DURING THE PROCEDURE, THE FILTER WAS UNABLE TO EXPAND. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23507951 ↗MalfunctionNov 10, 2025Activation Failure; Activation Failure
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. DURING THE PROCEDURE, THE FILTER WAS UNABLE TO EXPAND. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23507949 ↗MalfunctionNov 3, 2025Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. DURING THE PROCEDURE, THE FILTER GOT STUCK IN CATHETER. IT WAS FURTHER REPORTED THAT THERE WAS A DIFFICULTY IN RETRACTING THE DEVICE THROUGH INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23451581 ↗MalfunctionOct 31, 2025Activation Failure; Activation Failure
ON (B)(6) 2025, A 68-YEAR-OLD MALE PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING THE DENALI FILTER. DURING THE PROCEDURE, THE FILTER ALLEGEDLY DIDN'T TOTALLY OPEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23434137 ↗MalfunctionOct 24, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A FILTER PLACEMENT PROCEDURE USING DENALI DEVICE. DURING THE PROCEDURE, THE IVC FILTER WAS ALLEGEDLY STUCK INSIDE THE SHEATH AT THE SUPERIOR VENA CAVA AND INTERNAL JUGULAR. THE PHYSICIAN WAS ABLE TO MANIPULATE IT AND GET IT PASSED THE JUNCTIONS AND DEPLOYMENT WAS SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23380630 ↗MalfunctionJun 18, 2025Material Deformation; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. IN THE MIDST OF A FILTER PLACEMENT, THERE WAS SOMETHING IN THE FILTER THAT SEEMED LIKE BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22272867 ↗MalfunctionJun 3, 2025Premature Activation; Deformation Due to Compressive Stress; Premature Activation; Deformation Due to Compressive Stress
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI FILTER. DURING THE PROCEDURE, THE FILTER WAS ALLEGEDLY DEPLOYED INSIDE THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22129955 ↗MalfunctionMay 23, 2025Material Puncture/Hole; Material Puncture/Hole
ON (B)(6) 2025, AN 81-YEAR-OLD FEMALE PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER IMPLANTATION USING A DENALI JUGULAR FILTER VIA RIGHT INTERNAL JUGULAR VEIN. PRIOR TO THE PROCEDURE, THE FILTER WAS ALLEGEDLY PUNCTURED THROUGH THE SHEATH BEFORE IT ENTERED THE PATIENT. ANOTHER FILTER HAD TO BE OPENED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22077189 ↗MalfunctionMay 5, 2025Activation Failure; Activation Failure
ON (B)(6) 2025, A PATIENT UNDERWENT FOR INFERIOR VENA CAVA FILTER PLACEMENT WITH DENALI JUGULAR SYSTEM. DURING THE PROCEDURE THE FILTER ALLEGEDLY FAILED TO OPEN WHEN PLACED IN THE IVC. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21958282 ↗
Other FILTER, INTRAVASCULAR, CARDIOVASCULAR devices
- Denali® Vena Cava Filter DL900FBard Peripheral Vascular, Inc. · FILTER, INTRAVASCULAR, CARDIOVASCULAR22 deaths529 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
- Cook Celect G34505William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall1 death131 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.