LOBO LOBO-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850008222030), received between Jul 24, 2023 and Sep 11, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742873 ↗
• InjuryJul 24, 2023Migration; Migration

  PATIENT WAS TREATED FOR A SPLENIC ARTERY ANEURYSM MEASURING 2.5 - 3 CM. A LOBO-7 DEVICE WAS DEPLOYED IN THE SPLENIC ARTERY DISTAL TO THE ANEURYSM AND MIGRATED INTO AN UPPER POLE BRANCH OF THE SPLENIC ARTERY. THE DEVICE COULD NOT BE RETRIEVED WITH A SNARE AND THE PHYSICIAN ELECTED TO LEAVE IT IN PLACE. THE ANEURYSM WAS SUCCESSFULLY TREATED WITH LOBO-9 AND EMBOLIC COILS. THE SPLEEN WAS PARTIALLY INFARCTED, BUT NO LONG-TERM EFFECTS TO SPLENIC FUNCTION ARE ANTICIPATED BY THE PHYSICIAN. PATIENT WAS DISCHARGED FOLLOWING THE PROCEDURE WITH PAIN MEDICATION. THE PATIENT RETURNED TO THE HOSPITAL AND WAS ADMITTED FOR PAIN MANAGEMENT. DURING HOSPITALIZATION, THE PATIENT WAS TREATED FOR PAIN AND FLUID OVERLOAD (INCLUDING PULMONARY EDEMA), AND WAS SUBSEQUENTLY DISCHARGED.

  Patient problems: Device Embedded In Tissue or Plaque; Hypervolemia; Inadequate Pain Relief; Necrosis; Pain; Pulmonary Edema

  MAUDE report 17376052 ↗
• InjuryJul 24, 2023Migration; Migration

  PATIENT WAS TREATED FOR A SPLENIC ARTERY ANEURYSM MEASURING 2.5 - 3 CM. A LOBO-7 DEVICE WAS DEPLOYED IN THE SPLENIC ARTERY DISTAL TO THE ANEURYSM AND MIGRATED INTO AN UPPER POLE BRANCH OF THE SPLENIC ARTERY. THE DEVICE COULD NOT BE RETRIEVED WITH A SNARE AND THE PHYSICIAN ELECTED TO LEAVE IT IN PLACE. THE ANEURYSM WAS SUCCESSFULLY TREATED WITH LOBO-9 AND EMBOLIC COILS. THE SPLEEN WAS PARTIALLY INFARCTED, BUT NO LONG-TERM EFFECTS TO SPLENIC FUNCTION ARE ANTICIPATED BY THE PHYSICIAN. PATIENT WAS DISCHARGED FOLLOWING THE PROCEDURE WITH PAIN MEDICATION. THE PATIENT RETURNED TO THE HOSPITAL AND WAS ADMITTED FOR PAIN MANAGEMENT. DURING HOSPITALIZATION, THE PATIENT WAS TREATED FOR PAIN AND FLUID OVERLOAD (INCLUDING PULMONARY EDEMA), AND WAS SUBSEQUENTLY DISCHARGED.

  Patient problems: Device Embedded In Tissue or Plaque; Hypervolemia; Inadequate Pain Relief; Necrosis; Pain; Pulmonary Edema

  MAUDE report 17376047 ↗