Adelante Sigma ASG07010WRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885672008991), received between Oct 11, 2022 and Apr 10, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2023Break; Break

  THE PHYSICIAN WAS ATTEMPTING TO USE A MEDTRONIC EXPANDABLE STENT, A 7F ADELANTE SIGMA INTRODUCER SHEATH AND A 0.035" GUIDEWIRE TO TREAT A 76 YEAR OLD, MALE, WITH SEVERELY CALCIFIED LESION IN THE COMMON ILIAC ARTERY, WITH 50% STENOSIS. DURING THE PROCEDURE, THE CUSTOMER EXPERIENCED AN ISSUE WITH THE HEMOSTATIC VALVE BREAKING. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709203 ↗
• MalfunctionOct 11, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT "DR GRAHAM REPORTED THAT THE SHEATH WAS LEAKING FROM THE WIRE PORT A LOT AND WHEN ASPIRATED SUCKED BACK AIR" NORMAL USE (I.E., REPORTED EVENT OCCURS DURING THE LIFE OF AN IMPLANTED DEVICE; AFTER POST-OP AND BEFORE EXPLANT). LEAK OCCURRED AT HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15582664 ↗