ALN Optional Vena Cava Filter - Femoral Approach FF.010995Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03760017680004), received between Apr 30, 2021 and Jun 17, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2022Migration; Migration

  ON (B)(6) 2022, IN THE INTERVENTIONAL RADIOLOGY DEPARTMENT, THE PLACEMENT OF AN OPTIONAL VENA CAVA FILTER BY FEMORAL APPROACH IN A PATIENT WITH BILATERAL PULMONARY EMBOLISM WITH DEEP VEIN THROMBOSIS OF THE LOWER LIMBS FAILED. INDEED, SEVERAL ATTEMPTS TO RELEASE THE VENA CAVA WITHIN THE SUBRENAL VENA CAVA WERE MADE, RESULTING IN A RECOIL OF THE MATERIAL CAUDALLY TOWARDS THE ILIAC BIFURCATION. THE CRITICAL STEP WAS THE FIXED POINT-REMOVAL USING THE SUPPLIED PUSHER WHICH FAILED TO RELEASE THE FILTER. THE UNEXPANDED FILTER WAS FINALLY RELEASED THANKS TO THE DILATOR. A RADIOGRAPH CONFIRMED THE POOR DEPLOYMENT OF THE MATERIAL AND ITS MIGRATION IN THE SUPRARENAL SITUATION. THE MEDICAL TEAM THEREFORE ATTEMPTED TO RECOVER THE MATERIAL VIA THE SUPERIOR ROUTE (VIA THE JUGULAR APPROACH), BUT THIS FAILED BECAUSE THE ANGULATION OF THE INFERIOR VENA CAVA ABOVE THE KIDNEYS DID NOT ALLOW THE DEVICE TO BE REMOVED. ON (B)(6) 2022, A NEW ATTEMPT TO REMOVE THE FILTER WAS MADE, THE LATTER BEING LOCALIZED RETRO-HEPATICALLY. IN VIEW OF THE TWO SUCCESSIVE FAILURES TO REMOVE THIS FILTER, IT WAS DECIDED TO LEAVE IT IN PLACE FOR LIFE. THIS IS AN ISOLATED INCIDENT. THE CONSEQUENCES FOR THE PATIENT ARE MAINLY T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14732761 ↗
• MalfunctionFeb 24, 2022Migration; Migration

  WHEN INSERTING A VENA CAVA FILTER VIA THE FEMORAL ROUTE, THE DEVICE DID NOT DEPLOY CORRECTLY AND MIGRATED TO THE HEART. SIGNIFICANTLY LENGTHENED PROCEDURE. DEVICE RECOVERED BY LASSO IN JUGULAR AFTER TWO HOURS. NO CAVOGRAPHY IN THIS PATIENT WITH RENAL FAILURE. THE INDICATION FOR PLACEMENT IS MACROSCOPIC HEMATURIA, CONTRAINDICATING ANTICOAGULATION INITIALLY PLANNED FOR A PULMONARY EMBOLISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590068 ↗
• InjuryApr 30, 2021Entrapment of Device; Entrapment of Device

  EVENT: DUODENUM PERFORATION. ON (B)(6) 2020, THE PATIENT UNDERWENT AN IVC FILTER IMPLANTATION PROCEDURE. THE PATIENT HAD REGULARLY GOTTEN CHECKED UP OTHER UNDERLYING DISEASES AND UNDERWENT A CT SCAN. IT SHOWED PERFORATION BY THE FILTER. THE PATIENT UNDERWENT ENDOSCOPY TO CHECK MORE DETAILS ON (B)(6) 2021. IT WAS OBSERVED THE FILTER DEVICE PERFORATED THE DUODENUM. PATIENT'S CONDITION AFTER THE OPERATION: STABLE. PATIENT'S ANATOMY AFTER THE IMPLANTATION: THERE IS NO TORTUOSITY IN THE IMPLANTATION LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752482 ↗