Sofia DA6115ST-GC-ODRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429108444), received between Dec 14, 2023 and Jun 5, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN A RESTORE CLINICAL STUDY, THE NEXT DAY FOLLOWING THE MECHANICAL THROMBECTOMY PROCEDURE THAT WAS PERFORMED USING WITH THE SOFIA ASPIRATION CATHETER, THE PATIENT EXPERIENCED SUBARCHNOID HEMORRHAGE, AND THIS EVENT WAS SUMMARIZED AS A LEFT POSTERIOR INSULA WEDGE-SHAPED HYPODENSITY, REPRESENTING ACUTE/SUBACUTE CVA. THERE WAS NO TREATMENT PROVIDED, AS THE PATIENT WAS ONLY OBSERVED. NIHSS SCORE WAS NOTED TO BE 3 AND MRS SCORE WAS AT 4. ALTHOUGH REQUESTED, THERE WAS NO OTHER PATIENT INFORMATION PROVIDED BY THE SITE AT THIS TIME. IT WAS NOTED THAT THE RELATIONSHIP TO SOFIA DEVICE IS CONSIDERED POSSIBLY, THE RELATIONSHIP TO MECHANICAL THROMBECTOMY PROCEDURE IS CONSIDERED DEFINITELY, THE RELATIONSHIP TO STUDY DISEASE IS CONSIDERED POSSIBLY, AND THE RELATIONSHIP TO CONCURRENT CONDITION/TREATMENT IS CONSIDERED POSSIBLY.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22155645 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SOFAST STUDY THAT IMAGING TAKEN ONE DAY POST THROMBECTOMY REVEALED RE-OCCLUSION OF DISTAL LEFT M1 SEGMENT. FURTHER INTERVENTION VIA THROMBECTOMY WAS DECIDED TO BE FUTILE AND DECISION WAS MADE NOT TO RE-TREAT AND PLACED THE PATIENT ON MEDICATION ONLY. THE CLINICIAN NOTED THAT THE RE-OCCLUSION MAY HAVE OCCURRED DUE TO INTRACRANIAL ATHEROSCLEROSIS. THE EVENT WAS POSSIBLY RELATED TO THE STUDY DISEASE AND POSSIBLY TO CONCURRENT CONDITION. THE EVENT OUTCOME IS ONGOING.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18332278 ↗