Gateway® M0032072215220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729791188), received between May 16, 2016 and Feb 7, 2022 — classified as 1 injury, 1 malfunction.

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

• MalfunctionFeb 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A NEUROVASCULAR PROCEDURE WAS PERFORMED IN A PATIENT WITH INTRACRANIAL ARTERY STENOSIS IN MCA (MIDDLE CAROTID ARTERY). DURING THE PROCEDURE WHEN THE PHYSICIAN WAS NOT ABLE TO INFLATE THE SUBJECT BALLOON. THE PHYSICIAN REMOVED THE SUBJECT BALLOON FROM THE PATIENTS VASCULAR ANATOMY AND NOTED THAT THE SUBJECT BALLOON WAS RUPTURED. THE SUBJECT BALLOON WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472304 ↗
• InjuryMay 16, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH AN INTRACRANIAL ATHEROSCLEROTIC DISEASE OF THE LEFT M1 MIDDLE CEREBRAL (MCA) WITH 95% OF STENOSIS. IT WAS REPORTED THAT FOLLOWING ANGIOPLASTY USING THE FIRST BALLOON (SUBJECT DEVICE), A STENT WAS PLACED ACROSS THE MOST SEVERE STENOSIS OF THE LEFT M1 MCA. INITIALLY COMPLETE MCA REVASCULARIZATION WAS ACHIEVED; HOWEVER, FINAL ANGIOGRAMS SHOWED A SMALL FLAP DISSECTION AT THE END OF THE STENT. THE DISSECTION WAS TREATED WITH THE SECOND BALLOON AND ANOTHER MANUFACTURER'S STENT PLACED ACROSS THE DISSECTED LESION. THE PATIENT REMAINS INTUBATED OVERNIGHT. THE NEXT DAY, THE PATIENT SHOWED SIGNS OF THE REPERFUSION ISSUES. THE PATIENT BECAME GENERALLY WEAKER WITH MORE PRONOUNCED LEFT WEAKNESS. COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED RE-PERFUSION HYPEREMIA IN THE LEFT CEREBRAL HEMISPHERE WITH NO BLEEDING AND NO NEW STROKE. NO TREATMENT WAS REQUIRED AND SEVEN DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY FOR REHABILITATION. THE PATIENT HAD SIGNIFICANT RECOVERY OF FUNCTION PRIOR TO DISCHARGE WITH RETURN TO BASELINE AT THE REHABILITATION CENTER ONE WEEK AFTER DISCHARGE. THE EVENT WAS REPORTED AS RELATED TO THE PROCEDURE BUT UNRELATED TO DE

  Patient problems: Hyperemia; Vascular Dissection

  MAUDE report 5657886 ↗