Aura™ 1870+Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00051131499966), received between Jan 16, 2018 and Jan 16, 2018 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryJan 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AN OCCUPATIONAL HEALTH WORKER ALLEGED THAT A FEMALE, WHO IS A REGISTERED NURSE (RN), WORE A SURGICAL RESPIRATOR TO PERFORM PATIENT CARE FOR AN ISOLATION PATIENT. WITHIN THIRTY MINUTES OF WEARING THE SURGICAL RESPIRATOR, SHE BEGAN TO FEEL STRANGE AND THOUGHT SHE SMELLED LATEX IN THE SURGICAL RESPIRATOR. AFTER REMOVAL OF THE SURGICAL RESPIRATOR, THE RN CONTINUED TO FEEL UNWELL, WAS SEEN IN THE EMERGENCY ROOM, AND THEN ADMITTED TO THE HOSPITAL CRITICAL CARE UNIT, WHERE SHE REMAINED OVER THE WEEKEND. A MEDICAL DOCTOR WHO IS AN ALLERGIST CONTACTED 3M AND ALLEGED THAT THE RN EXPERIENCED ANAPHYLAXIS, WHERE THE SYMPTOMS INCLUDED SHORTNESS OF BREATH, THROAT TIGHTNESS, PROFUSE RHINORRHEA AND HYPOTENSION, WHICH RESULTED AFTER THE FIRST-TIME USE OF THIS TYPE OF SURGICAL RESPIRATOR WORN BY THE RN. THE RN WAS HOSPITALIZED THE SAME DAY ON (B)(6) 2017, AND WAS DISCHARGED ON (B)(6) 2017. SHE WAS GIVEN EPINEPHRINE, STEROIDS AND AN ANTIHISTAMINE IN THE EMERGENCY ROOM, AND THERAPY WAS CONTINUED WITH EPINEPHRINE AND STEROIDS DURING THE HOSPITAL STAY. THE CURRENT STATUS OF THE (RN) IS FINE ACCORDING TO THE DOCTOR.

  Patient problems: High Blood Pressure/ Hypertension; Patient Problem/Medical Problem; Respiratory Distress

  MAUDE report 7195317 ↗