Medical device recalls, whether voluntary or mandated, are crucial for ensuring patient safety.
Here are four significant recalls reported to the FDA since late October:
1. Draeger recalls anesthesia workstations
Draeger recalled its Atlan A350 and A350 XL anesthesia workstations Nov. 19 due to a manufacturing issue that may cause the ventilator to fail during use. The failure could result in inadequate ventilation, posing a risk of oxygen deprivation or cardiac arrest. There have been 62 complaints related to this issue, including one reported death.
2. Percussionaire recalls Phasitron 5 breathing circuits
Percussionaire Corporation recalled certain lots of its Phasitron 5 breathing circuits Nov. 1 due to the presence of nickel coating on a component. The nickel coating may react with saline and other substances during use, potentially leading to aerosolization of nickel and exposing patients to harmful levels. The recall affects devices used in intrapulmonary percussive ventilation therapy, with three reported injuries but no deaths.
3. Phillips recalls Trilogy ventilators
Phillips Respironics recalled several models of its Trilogy ventilators Nov. 19 due to inaccurate flow measurements caused by improper placement of in-line nebulizers. Aerosol deposits may accumulate on the internal flow sensor, leading to either excessive or insufficient airflow, which can result in respiratory distress or lung damage. There have been four reported injuries, but no deaths have been reported.
4. Smiths Medical recalls tracheostomy tube kits
Smiths Medical recalled specific lots of its BLUselect, BLUgriggs and BLUperc tracheostomy tube kits Oct. 25 due to a defect that may cause the pilot balloon to disconnect from the inflation line. If this occurs, the cuff may lose pressure, potentially leading to inadequate ventilation and aspiration risk. The recall has resulted in 12 reported injuries but no fatalities.