DENALI Vena Cava FilterRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,021
- Deaths reported
- 37
- Injuries reported
- 391
- Recalls
- 0
We found 2 models of DENALI Vena Cava Filter by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 1,021 adverse event reports in the FDA's MAUDE database, received between Oct 21, 2014 and Sep 28, 2026 — classified as 37 deaths, 391 injuries, 593 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (292 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DENALI Vena Cava Filter problems
Device problems
- Malposition of Device292
- Difficult to Remove227
- Patient Device Interaction Problem224
- Patient-Device Incompatibility157
- Detachment of Device or Device Component151
- Adverse Event Without Identified Device or Use Problem111
- Activation Failure110
- Migration or Expulsion of Device105
Patient problems
- No Clinical Signs, Symptoms or Conditions327
- No Consequences Or Impact To Patient312
- Pulmonary Embolism145
- Abdominal Pain109
- Thrombus52
- Thrombosis/Thrombus48
- Death34
- Pain34
DENALI Vena Cava Filter models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Denali® Vena Cava Filter DL900FFILTER, INTRAVASCULAR, CARDIOVASCULAR22 deaths529 reports
- DENALI® Vena Cava Filter DL900JFILTER, INTRAVASCULAR, CARDIOVASCULAR15 deaths492 reports
Recent DENALI Vena Cava Filter adverse event reports
The 15 most recent reports across all models, 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 ↗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 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 ↗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 ↗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 ↗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 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 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 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 ↗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 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
- Dorado49 models · 387 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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