Skip to content

GateWay™ PLUS M001153220Recalls & reported problems

Boston Scientific Corporation · Y-Adapter · Class 2

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 08714729734604), received between Apr 1, 2019 and Apr 1, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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

  • Crack1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 1, 2019Crack; Crack

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT THERE WAS A CRACK ON THE DEVICE. A 10PK GATEWAY PLUS WAS SELECTED FOR USE. DURING THE PREPARATION, IT WAS NOTED THAT THERE WAS A CRACK ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER,A ANALYSIS REVEALED THAT THERE WAS A SMALL PIECE OF A FOREIGN MATTER THAT LOOKS LIKE PLASTIC AND IT CAUSED AN OPTICAL EFFECT THAT SEEMED TO BE A CRACK IN THE DEVICE MATERIAL.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8469926 ↗

Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices

All Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.