Gateway® M0032072209150Recalls & reported problems
Boston Scientific Corporation · PTA Balloon Catheter · Class f
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729791201), received between Jun 1, 2016 and Dec 27, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Hole In Material” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Hole In Material1
Patient problems
- Hemorrhage, Subarachnoid1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2017Hole In Material; Hole In Material
IT WAS REPORTED THAT THE BALLOON WAS FOUND NOT TO BE SEALED DURING THE PROCEDURE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7149795 ↗InjuryJun 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FOLLOWING ANGIOPLASTY WITH A BALLOON CATHETER (SUBJECT DEVICE), A STENT WAS PLACED ACROSS THE TARGET 90% STENOSED RIGHT POSTERIOR CEREBRAL ARTERY (PCA) LESION. IT WAS REPORTED THAT A SUBARACHNOID HEMORRHAGE (SAH) OCCURRED AFTER THE STENT DEPLOYMENT. A COMPUTER TOMOGRAPHY (CT) SCAN CONFIRMED SAH WITH NO EVIDENCE OF A NEW STROKE OR MASS EFFECT. THE SAH LOCATION WAS RIGHT OCCIPITAL-RIGHT PARIETAL LOBE DISTAL TO THE TREATED AREA. INTRA-ARTERIAL INJECTION OF TAMPONADE AND PROTAMINE WERE GIVEN TO THE PATIENT. THERE WERE NO CLINICAL SYMPTOMS AND ON THE SAME DAY, THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS. SIX DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED. THE EVENT WAS REPORTED AS RELATED TO THE PROCEDURE BUT UNRELATED TO EITHER DEVICE.
Patient problems: Hemorrhage, Subarachnoid
MAUDE report 5691806 ↗
Other intracranial neurovascular stent devices
- CERENOVUS ENTERPRISE ENF402312Medos International Sàrl · intracranial neurovascular stent1 death90 reports
- PulseRider Aneurysm Neck Reconstruction Device 201-DMedos International Sàrl · Intracranial Neurovascular Stent2 deaths74 reports
- CERENOVUS ENTERPRISE ENF402300Medos International Sàrl · intracranial neurovascular stent2 deaths66 reports
- CERENOVUS ENTERPRISE ENF403012Medos International Sàrl · intracranial neurovascular stent1 death42 reports
- CERENOVUS ENTERPRISE ENF452212Medos International Sàrl · intracranial neurovascular stent41 reports
- CERENOVUS ENTERPRISE ENF401600Medos International Sàrl · intracranial neurovascular stent36 reports
- CERENOVUS ENTERPRISE ENF401612Medos International Sàrl · intracranial neurovascular stent36 reports
- CERENOVUS ENTERPRISE ENF452812Medos International Sàrl · intracranial neurovascular stent31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page