SOFIA 88 DA8115ST-DAC-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429117705), received between May 29, 2025 and May 29, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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.

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.

• InjuryMay 29, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PHYSICIAN USED THE SOFIA 88 FOR A STROKE PATIENT THAT HAD AN ICA TERMINUS OCCLUSION. THE PHYSICIAN PLACED THE SOFIA 88 AT THE DISTAL ICA TERMINUS AND PROCEEDED TO ASPIRATE. THE SOFIA MOVED FORWARD INTO THE MIDDLE CEREBRAL ARTERY DURING ASPIRATION. AFTER THE INITIAL PASS, AN ANGIOGRAM WAS PERFORMED AND THE OCCLUSION WAS CLEARED BUT SHOWED IRREGULARITY OF THE MCA. THE MIDDLE CEREBRAL ARTERY RECEIVED INJURY WHILE THE SOFIA 88 WAS ASPIRATING. NO FURTHER TESTING OTHER THAN THE ANGIOGRAPHIC IMAGES DONE POST THROMBECTOMY. THE PHYSICIAN PROVIDED HEPARIN. THE PATIENT CONDITION AND OUTCOME WAS REPORTED TO BE GOOD. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO FURTHER TESTING DONE OTHER THAN THE ANGIOGRAPHIC IMAGES DONE POST THROMBECTOMY AND THE PHYSICIAN GAVE HEPARIN. PLEASE SEE H6 & H11.

  Patient problems: Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 22103169 ↗