Adelante Sigma ASG12023Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885672101050), received between Jul 23, 2020 and Jul 23, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PREPARATION OF THE ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE, THE DOCTOR TRIED TO INSERT THE DILATOR INTO THE SHEATH. THIS DID NOT WORK. THEREFORE THE PHYSICIAN TRIED TO INSERT THE DILATOR WITH PRESSURE INTO THE SHEATH, BUT ALSO WITH PRESSURE HE WAS NOT ABLE TO PUSH THE DILATOR THROUGH THE SHEATH. THEN THE PHYSICIAN TRIED TO PULL THE DILATOR OUT WITH PRESSURE AND DURING THIS PROCESS THE HEMOSTATIC VALVE DETACHED. NO PATIENT WAS INVOLVED BECAUSE THE PRODUCT ISSUE WAS FOUND PRIOR TO THE PROCEDURE, DURING THE PREPARATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADELANTE SIGMA 12F FROM THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10314432 ↗