Stroke Fast Pack 91315Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327500677), received between Aug 22, 2023 and Aug 22, 2023 — classified as 1 injury.

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

• InjuryAug 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ACUTE ISCHEMIC STROKE PROCEDURE WHERE THE MCA (MIDDLE CEREBRAL ARTERY) WAS OCCLUDED, PHYSICIAN FELT RESISTANCE WHILE ADVANCING AND RETRACTING THE SUBJECT STENT RETRIEVER INSIDE THE MICROCATHETER SHAFT. WHILE RETRACTION UNDER ASPIRATION, THE SUBJECT STENT RETRIEVER DETACHED FROM THE DELIVERY WIRE. THE SUBJECT STENT RETRIEVER WAS KINKED AND NARROWED IN THE VESSEL. PHYSICIAN TRIED TO RETRIEVE THE SUBJECT STENT RETRIEVER BUT WAS LEFT INSIDE THE PATIENT'S ANATOMY. M1 VESSEL REMAINED OCCLUDED AND DYNA CT REVEALED A BLEED POST PROCEDURE. PHYSICIAN WAS NOT CERTAIN IF THE BLEEDING WAS CAUSED BY THE SUBJECT STENT RETRIEVER. VASOSPASM WAS ALSO NOTED DURING THE PROCEDURE. PATIENT'S ANATOMY WAS VERY TORTUOUS. PHYSICIAN GAVE INTEGRILIN AT THE END OF THE PROCEDURE. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND THE PATIENT IS STILL IN ICU. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Vasoconstriction

  MAUDE report 17600495 ↗