Gateway® M0032072215150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729791300), received between Sep 20, 2016 and Dec 27, 2021 — classified as 2 injuries, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SUBJECT BALLOON COULD NOT INFLATE DURING AN INTRACRANIAL ARTERY STENOSIS PROCEDURE. UPON REMOVAL, THE PHYSICIAN NOTED THE BALLOON (SUBJECT DEVICE) HAS RUPTURED. THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087159 ↗
• InjurySep 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT STENT ASSISTED BALLOON(SUBJECT DEVICE) ANGIOPLASTY OF THE BASILAR TRUNK ARTERY STENOSIS WITH THE SUCCESSFUL IMPLANTATION OF THE FIRST STENT. IT WAS REPORTED THAT DURING THE PLACEMENT OF THE SECOND STENT, THE STENT FAILED TO OPEN AND HENCE IT WAS NOT IMPLANTED. THE NEXT DAY OF THE PROCEDURE, TRACE AMOUNT OF SUBARACHNOID HEMORRHAGE WITHIN INTERPEDUNCULAR AND PREPONTINE CISTERN WAS OBSERVED. THE HEMORRHAGE WAS RESOLVED WITHOUT ANY RESIDUAL EFFECTS. NO TREATMENT WAS ADMINISTERED IN THE PHYSICIAN¿S OPINION, THE CAUSE OF THE HEMORRHAGE IS RELATED TO THE PROCEDURE; HOWEVER, RELATIONSHIP TO THE STENT AND THE BALLOON IS UNKNOWN.

  Patient problems: Hemorrhage, Subarachnoid

  MAUDE report 6874367 ↗
• InjurySep 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WITH A BASELINE OF A MODIFIED RANKIN SCALE (MRS) OF 3 UNDERWENT SUCCESSFUL STENT ASSISTED BALLOON ANGIOPLASTY OF THE 87 % STENOSED LEFT MIDDLE CEREBRAL ARTERY (L MCA). IT WAS REPORTED THAT POST PROCEDURE THE PATIENT EXPERIENCED A STROKE IN THE BASAL GANGLIA (TREATED AREA). THE PATIENT STROKE WAS ASSESSED AS A MRS OF 4 WITH A NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 12. IT WAS REPORTED THAT MEDICAL THERAPY AND REHABILITATION HAVE BEEN PROVIDED AND IT IS STILL ONGOING. AT DISCHARGE THE PATIENT HAD RESIDUAL APHASIA AND RIGHT SIDED WEAKNESS. UPON DISCHARGE THE PATIENT WAS REPORTED TO HAVE A MRS OF 4 WITH A NIHSS OF 9. THE STUDY FACILITY INDICATED THAT THE RELATIONSHIP OF THE PROCEDURE TO THE STROKE WAS NOT RELATED; HOWEVER, TO THE DEVICE WAS UNKNOWN.

  Patient problems: Infarction, Cerebral; Neurological Deficit/Dysfunction

  MAUDE report 5963866 ↗