TEMNO EVOLUTION CTT1811Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403089343), received between Jan 15, 2020 and Jul 1, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2020Fracture; Material Separation; Detachment of Device or Device Component; Fracture; Material Separation; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT DURING LUNG BIOPSY PROCEDURE, THE BIOPSY NEEDLE TIP DETACHED WITHIN THE PATIENT. THE DETACHED TIP WAS LEFT WITHIN THE PATIENTS [LUNG] TUMOR. THE ACCOUNT STATES THAT THE TIP WILL BE EXCISED FROM THE TUMOR AT A LATER DATE. PATIENT WAS DISCHARGED TO HOME AS EXPECTED, PAIN FREE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10221200 ↗
• InjuryJan 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT DURING LUNG BIOPSY PROCEDURE, THE BIOPSY NEEDLE TIP DETACHED WITHIN THE PATIENT. THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH COPD AND SUFFERED FROM AICHMOPHOBIA. THE HOSPITAL ALLEGED THAT THE PATIENT WOULD NOT LIE STILL DURING THE BIOPSY PROCEDURE. EVENTUALLY THE PATIENT'S OXYGEN SATURATIONS STARTED TO DECREASE, AND A CODE WAS CALLED. HOSPITAL BLS PROTOCOLS WERE ADMINISTERED REQUIRING INTUBATION AND NECESSARY RESUSCITATION ATTEMPTS. THE NEEDLE TIP WAS SUCCESSFULLY REMOVED VIA SURGICAL EXCISION.

  Patient problems: Foreign Body In Patient

  MAUDE report 9594321 ↗