ALN Optional Vena Cava Filter - Femoral Approach with Hook FF.HOOKRecalls & reported problems
A.L.N. · The device is an Optional Vena Cava Filter - Femoral Kit with Hook. It consists of a nine legs 316L stainless steel filter with a hook at the apex supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03760017680042), received between Feb 7, 2019 and Jul 17, 2025 — classified as 1 death, 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Slipped1
- Entrapment of Device1
- Fracture1
- Improper or Incorrect Procedure or Method1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Exsanguination1
- Failure of Implant1
- Hematoma1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2025Fracture; Fracture
THE FILTER WAS PLACED ON THE (B)(6) 2024 AND REMOVED ON (B)(6) 2025.LASSO TECHNIQUE WAS USED FOR THE FILTER REMOVAL (COOK CLOVERSNARE®).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22529990 ↗MalfunctionFeb 24, 2023Migration; Migration
UPON DEPLOYMENT OF IVC FILTER, MIGRATED TO THE LEVEL OF THE PULMONARY ARTERY. THE PHYSICIAN WAS ABLE TO SNARE AND REMOVE THE FILTER IN ITS ENTIRETY.
Patient problems: Failure of Implant
MAUDE report 16434056 ↗InjuryDec 9, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IMPLANTATION BY RIGHT FEMORAL APPROACH FOLLOWING FLOATING VENOUS THROMBUS IN FEMORAL VEIN IN LEFT LIMB. INCOMPLETE OPENING OF THE FILTER LEADING TO MIGRATION TO THE LEFT PULMONARY ARTERY. FILTER REMOVED FROM THE PULMONARY ARTERY WITH A LASSO BUT ANCHORED STRONGLY IN RIGHT ILIAC VEIN IN A TRANSVERSE POSITION. DECISION TO LEAVE THE FILTER IN THAT POSITION AFTER MULTIPLE ATTEMPTS OF EXTRACTION USING A SNARE AND THE FILTER EXTRACTION KIT BOTH VIA FEMORAL AND JUGULAR ROUTES. SUCCESSFUL IMPLANTATION OF A SECOND FILTER BY JUGULAR APPROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10975548 ↗DeathFeb 7, 2019Entrapment of Device; Device Slipped; Entrapment of Device; Device Slipped
A (B)(6) FEMALE WITH PAST MEDICAL HISTORY OF RECURRENT DEEP VEIN THROMBOSIS AND PULMONARY THROMBOEMBOLI, HYPERTENSION, AND COPD PRESENTED ON (B)(6) 2019 WITH COMPLAINT OF RIGHT UPPER QUADRANT ABDOMINAL PAIN AND WAS DIAGNOSED WITH ACUTE CHOLECYSTITIS. SHE UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY AND PLACEMENT OF INFERIOR VENA CAVE FILTER. PT WAS DISCHARGED ON (B)(6) 2019. AFTER DISCHARGE, PT WAS FOUND DECEASED. AUTOPSY WAS REQUESTED BY PATIENT'S FAMILY. ANATOMIC PRELIMINARY DIAGNOSIS FOUND RETROPERITONEAL HEMORRHAGE (RIGHT RETROPERITONEAL HEMATOMA, SIX STRUTS OF AN INFERIOR VENA CAVA FILTER PERFORATING THE WALL OF THE INFERIOR VENA CAVA). THE AUTOPSY FINDINGS NOTED THAT THE CHOLECYSTECTOMY SURGICAL BED WAS FREE OF UNDUE HEMORRHAGE OR EVIDENCE OF INFECTION. THE AUTOPSY FINDINGS ARE PRELIMINARY. HISTOLOGIC EXAMINATION IS PENDING.
Patient problems: Exsanguination; Hematoma
MAUDE report 8358178 ↗
Other Filter, Intravascular, Cardiovascular devices
- Denali® Vena Cava Filter DL900FBard Peripheral Vascular, Inc. · FILTER, INTRAVASCULAR, CARDIOVASCULAR22 deaths529 reports
- DENALI® Vena Cava Filter DL900JBard Peripheral Vascular, Inc. · FILTER, INTRAVASCULAR, CARDIOVASCULAR15 deaths492 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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