Key Takeaways
- Smiths Medical recalled more than 850,000 tracheostomy kits due to a defect that can cause the balloon to detach from the inflation line, leading to serious risks for patients.
- More than 10 injuries have been reported in connection with the defect, and the recall has been classified as Class I by the FDA, indicating the potential for severe injury or death.
- This is Smiths Medical’s seventh Class I recall in 2024, following ongoing quality and safety challenges.
- Another recall involving Smiths Medical’s ParaPac ventilator kits has also been issued, affecting over 12,000 units due to a malfunction with the tidal volume knob.
- ICU Medical, which acquired Smiths in 2022, has faced challenges in addressing safety and quality control issues within Smiths Medical’s product lines.
Medical device manufacturer Smiths Medical has initiated a recall of tracheostomy kits due to a defect that could result in the separation of the balloon from the inflation line. This defect, which affects over 850,000 units, including the Portex Bluselect, Blugriggs, and Bluperc kits, poses serious risks to patients requiring airway management. According to the U.S. Food and Drug Administration (FDA), the recall is classified as Class I, indicating the potential for severe injury or death.
Smiths Medical has reported more than 10 cases of serious injuries linked to this issue, prompting the company to instruct healthcare providers to discard the affected products and request replacements or credits. This marks Smiths Medical’s seventh Class I recall in 2024, underscoring ongoing safety and quality control concerns within the company, which was acquired by ICU Medical in 2022 for $2.35 billion.
Medical Device Recall: Smiths Medical Faces New Recall Over Defective Tracheostomy Tubes After Similar Incident Linked to Injuries and Death
The defect in the latest recall by Smiths Medical pertains to the detachment of the pilot balloon from the inflation line in tracheostomy kits, a crucial issue that could lead to inadequate ventilation for patients. When the pilot balloon becomes detached, it can cause the tracheostomy cuff to lose pressure, severely compromising the patient’s ability to breathe. In such cases, the risk of aspiration, or the inhalation of foreign materials into the lungs, significantly increases, potentially leading to life-threatening complications. Smiths Medical has already reported more than 10 serious injuries linked to this defect.
This recall affects more than 850,000 units across various product lines, including Portex Bluselect, Blugriggs, and Bluperc kits, according to the Food and Drug Administration (FDA) database. Given the potential severity of the issue, the recall has been classified as a Class I recall, which is reserved for situations where the use of a defective product could cause serious injury or death. This marks the seventh Class I recall that Smiths Medical has issued in 2024, highlighting ongoing quality control issues within the company.
This is not the first time Smiths Medical has faced such a recall. In May 2024, the company recalled its Bivona line of tracheostomy tubes due to a similar manufacturing defect. That recall was tied to one reported death and 35 injuries, raising significant concerns about the safety and reliability of the company’s products. These recurring issues underscore the challenges Smiths Medical faces in maintaining product quality and safety, particularly as it has already received a warning letter from the FDA in 2021.
Medical Device Challenges: ICU Medical Faces Ongoing Safety and Quality Issues After Smiths Medical Acquisition
The parent company, ICU Medical, which acquired Smiths Medical in 2022 for $2.35 billion, has been grappling with these challenges. Vivek Jain, CEO of ICU Medical, acknowledged the difficulties, stating that the acquisition has been “more challenging than we had expected” due to the ongoing safety and quality issues. Despite these setbacks, ICU Medical remains committed to addressing the quality concerns that have led to repeated recalls and adverse events.
As Smiths Medical works to manage the recall, it has instructed customers to discard all affected products and reach out to their representatives for a replacement device or credit. Additionally, the FDA posted another recall involving Smiths Medical’s ParaPac ventilator kits, further complicating the company’s efforts to regain trust in its medical devices. The ParaPac recall affects over 12,000 units, with concerns that the tidal volume knob could inadvertently shift, affecting the amount of air delivered to patients during ventilation. These recalls reflect ongoing challenges in the company’s manufacturing processes and raise concerns about patient safety.
In addition to the tracheostomy kit recall, the FDA has also posted another recall for Smiths Medical, involving ParaPac ventilator kits. This issue, affecting more than 12,000 devices, relates to a malfunction in the tidal volume knob, which can shift from its original setting, potentially leading to dangerous complications for patients.
Resource: Food and Drug Administration, September 11, 2024
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