TEMNO Evolution® 10884450443429Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884450443429), received between May 13, 2024 and May 14, 2024 — classified as 1 death, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING A BIOPSY PROCEDURE. POST-BIOPSY PROCEDURE THE PATIENT PRESENTED WITH AIR EMBOLI SYMPTOMS. MEDICAL INTERVENTION WAS NECESSARY TO PREVENT PERMANENT IMPAIRMENT. SUPPORTIVE THERAPY CONSISTING OF SUPPLEMENTAL OXYGEN ADMINISTRATION, INTRAVASCULAR VOLUME EXPANSION, AND BLOOD PRESSURE SUPPORT WAS ATTEMPTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 19315112 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING A BIOPSY PROCEDURE. POST-BIOPSY PROCEDURE THE PATIENT PRESENTED WITH AIR EMBOLI SYMPTOMS. MEDICAL INTERVENTION WAS NECESSARY TO PREVENT PERMANENT IMPAIRMENT. SUPPORTIVE THERAPY CONSISTING OF SUPPLEMENTAL OXYGEN ADMINISTRATION, INTRAVASCULAR VOLUME EXPANSION, AND BLOOD PRESSURE SUPPORT WAS ATTEMPTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 19306715 ↗
• DeathMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING A BIOPSY PROCEDURE. POST-BIOPSY PROCEDURE THE PATIENT PRESENTED WITH AIR EMBOLI SYMPTOMS. MEDICAL INTERVENTION WAS NECESSARY TO PREVENT PERMANENT IMPAIRMENT. SUPPORTIVE THERAPY CONSISTING OF SUPPLEMENTAL OXYGEN ADMINISTRATION, INTRAVASCULAR VOLUME EXPANSION, AND BLOOD PRESSURE SUPPORT WAS ATTEMPTED. THE PATIENT WAS TREATED IN A HYPERBARIC CHAMBER IN AN ATTEMPT TO BETTER MANAGE THEIR CONDITION HOWEVER THIS WAS NOT SUCCESSFUL. THE PATIENT HAD EXPERIENCED SUSTAINED SEIZURES AFTER THE INCIDENT AS WELL AND ALL ATTEMPTS TO REDUCE PROCEDURE SEDATION WERE UNSUCCESSFUL. EVENTUALLY, THE PATIENT SUCCUMBED TO THE EFFECTS OF THE INCIDENT AND DIED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 19306714 ↗