LOBO LOBO-3Recalls & reported problems
Okami Medical, Inc. · Peripheral Vascular Occluder · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850008222016), received between Mar 16, 2026 and Sep 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Migration” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Migration1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742876 ↗MalfunctionMar 16, 2026Migration
IT WAS REPORTED THAT A PATIENT UNDERGOING AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE HAD A BRANCH OF THE INFERIOR MESENTERIC ARTERY (IMA) IDENTIFIED AS A POTENTIAL FEEDER VESSEL. THE PHYSICIAN ELECTED TO OCCLUDE THE VESSEL TO REDUCE THE RISK OF A FUTURE ENDOLEAK AND DEPLOYED A LOBO-3 OCCLUDER. THE PHYSICIAN ESTIMATED THE VESSEL DIAMETER TO BE BETWEEN 3-4 MM AND PROCEEDED WITH USE OF THE DEVICE OUTSIDE ITS INTENDED VESSEL SIZE RANGE, ACKNOWLEDGING AN INCREASED RISK OF MIGRATION. THE STENT GRAFT WAS SUBSEQUENTLY PLACED AND EXPANDED. APPROXIMATELY 5 MINUTES AFTER LOBO DEPLOYMENT, THE PHYSICIAN OBSERVED THAT THE DEVICE HAD MIGRATED APPROXIMATELY 5 MM. A POST-PROCEDURE MEASUREMENT DETERMINED THE VESSEL DIAMETER TO BE 4.08 MM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613621 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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