LOBO LOBO-9Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850008222061), received between Dec 30, 2025 and Sep 30, 2026 — classified as 1 death, 6 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Human-Device Interface Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50955051 ↗
• MalfunctionSep 30, 2026Human-Device Interface Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50955049 ↗
• MalfunctionSep 11, 2026No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742870 ↗
• MalfunctionSep 11, 2026No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742867 ↗
• MalfunctionApr 3, 2026Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  A REPRESENTATIVE REPORTED THAT DURING A PAVM PROCEDURE, A LARGE PULMONARY ARTERY BRANCH DID NOT ACHIEVE OCCLUSION APPROXIMATELY 20 MINUTES AFTER A LOBO-9 VASCULAR OCCLUSION SYSTEM DEVICE WAS DETACHED IN THE INTENDED VESSEL. THE VESSEL WAS REPORTED TO MEASURE APPROXIMATELY 8 MM IN DIAMETER. THE PHYSICIAN WAITED AN ADDITIONAL FIVE (5) MINUTES AND SUBSEQUENTLY DEPLOYED A SECOND LOBO-9 DEVICE PROXIMAL TO THE INITIAL DEVICE. AFTER AN ADDITIONAL 15 MINUTES, FLOW WAS OBSERVED TO DECREASE; HOWEVER, COMPLETE OCCLUSION WAS NOT ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779630 ↗
• MalfunctionMar 25, 2026Migration

  IT WAS REPORTED THAT A PATIENT WITH AN ENLARGED SPLEEN AND NO EVIDENCE OF ACTIVE SPLENIC BLEEDING WAS SCHEDULED TO UNDERGO A SPLENECTOMY. THE PHYSICIAN ELECTED TO PERFORM A SPLENIC ARTERY EMBOLIZATION PRIOR TO SURGERY TO REDUCE BLEEDING RISK. THE TARGET VESSEL WAS REPORTED TO MEASURE APPROXIMATELY 6.8 MM IN DIAMETER. A LOBO-9 VASCULAR OCCLUSION SYSTEM DEVICE WAS SELECTED AND DEPLOYED FOR EMBOLIZATION. FOLLOWING DEVICE DEPLOYMENT AND DETACHMENT, IT WAS REPORTED THAT THE LOBO-9 DEVICE MIGRATED FORWARD BY APPROXIMATELY 1 CM FROM THE INTENDED PLACEMENT LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687166 ↗
• DeathDec 30, 2025Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT UNDERWENT PORTAL VEIN THROMBECTOMY AND THROMBOLYSIS, ALONG WITH PLUG-ASSISTED ANTEROGRADE TRANSVENOUS OBLITERATION (PATO) VIA A PERCUTANEOUS TRANSHEPATIC APPROACH, TO REDUCE THE RISK ASSOCIATED WITH RECENTLY BLEEDING HIGH-RISK GASTRIC VARICES AND TO RESTORE PATENCY OF THE MAIN PORTAL VEIN THROMBUS. SUCCESSFUL VARIX EMBOLIZATION WAS ACHIEVED USING THE LOBO VASCULAR OCCLUSION SYSTEM DEVICES AND GELFOAM BY THE CONCLUSION OF THE PROCEDURE. THE PATIENT WAS DISCHARGED TO FLOOR ROOM IN STABLE CONDITION WITHOUT ANY CONCERNS. OVERNIGHT ON (B)(6) 2025, THE PATIENT BEGAN BLEEDING AND WAS BROUGHT EMERGENTLY FOR ACTIVE HEMORRHAGE FROM THE GASTRIC VARIX (AS NOTED BY EMERGENT BEDSIDE UPPER ENDOSCOPY). THE PATIENT BECAME ANEMIC/UNSTABLE AND THUS WAS AGGRESSIVELY RESUSCITATED IN A 'MASSIVE TRANSFUSION PROTOCOL' (MTP) FASHION. EMERGENT TIPS WAS CREATED FOR PORTAL ACCESS AND PORTAL HYPERTENSION DECOMPRESSION. PORTAL VENOGRAPHY DEMONSTRATED PATENT RECENTLY EMBOLIZED VARIX VESSELS - WITH ACTIVE EXTRAVASATION FROM THE GASTRIC VARIX ON THE OTHER SIDE OF THE LOBO VASCULAR OCCLUDERS. TO ADDRESS THE VARIX BLEED, ONE OF THE LOBO VASCULAR OCCLUDERS WAS REPORTED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23931098 ↗