Gateway® M0032072215300Recalls & reported problems
Boston Scientific Corporation · PTA Balloon Catheter · Class f
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729791393), received between Mar 8, 2017 and Mar 8, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2017Leak/Splash; Leak/Splash
DURING THE INSPECTION, IT WAS REPORTED THAT THE SUBJECT BALLOON FOUND LEAKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 6390347 ↗
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- 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 ENF401612Medos International Sàrl · intracranial neurovascular stent36 reports
- CERENOVUS ENTERPRISE ENF401600Medos 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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