Covidien: Device Recall

Recall Details

Recall Number

Z-1390-2025

Classification

Class I

Product Type

Device

Recalling Firm

Covidien

Status

Ongoing

Date Initiated

02/26/2025

Location

Boulder, CO, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

780

Reason for Recall

Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.

Product Description

Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R

Distribution Pattern

OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan

Other Recalls by Covidien

• Class II: Risk 06/23/2025
  Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
• Class I: Dangerous 05/21/2025
  Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
• Class I: Dangerous 07/09/2024
  Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
• Class II: Risk 07/09/2024
  IFU update to address device's battery handling information.
• Class I: Dangerous 07/09/2024
  Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.

View all recalls by Covidien →