Emerge™ H7493919120200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729806912), received between Nov 5, 2024 and Nov 6, 2024 — classified as 2 injuries.

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.

• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AGENT PAS REGISTRY IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTRA/POST PROCEDURE EVENT OF CARDIOGENIC SHOCK. THE FOLLOWING EVENT, BASED ON DATA FROM THE AGENT PAS REGISTRY, IS BEING REPORTED AS A POSSIBLE DUPLICATE OF AN EVENT THAT WAS ALREADY KNOWN TO BSC AND REPORTED AS AN MDR WHEN THE EVENT OCCURRED. BSC REPORTS THE EVENTS IN COMPLIANCE TO 21 CFR 803.3. BECAUSE AGENT PAS REGISTRY DATA IS DE-IDENTIFIED BEFORE BEING TRANSMITTED TO BSC, THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED TO BSC. INITIAL REPORTER IS NOT PROVIDED DUE TO THE TERMS OF THE AGENT PAS REGISTRY.

  Patient problems: Cardiogenic Shock

  MAUDE report 20616402 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AGENT PAS REGISTRY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTRA/POST PROCEDURE EVENT OF CARDIOGENIC SHOCK. THE FOLLOWING EVENT, BASED ON DATA FROM THE AGENT PAS REGISTRY, IS BEING REPORTED AS A POSSIBLE DUPLICATE OF AN EVENT THAT WAS ALREADY KNOWN TO BSC AND REPORTED AS AN MDR WHEN THE EVENT OCCURRED. BSC REPORTS THE EVENTS IN COMPLIANCE TO 21 CFR 803.3. BECAUSE AGENT PAS REGISTRY DATA IS DE-IDENTIFIED BEFORE BEING TRANSMITTED TO BSC, THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED TO BSC. INITIAL REPORTER IS NOT PROVIDED DUE TO THE TERMS OF THE AGENT PAS REGISTRY.

  Patient problems: Cardiogenic Shock

  MAUDE report 20615356 ↗