Baxter Issues Class I Recall for Volara System Circuit and Ventilator Adaptor

Deerfield, Illinois-based healthcare company Baxter International Inc. has issued an Urgent Medical Device Recall for some lots of the Volara system single-patient use circuit and blue ventilator adapter assembly.

The company said it is recalling the product due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. No injuries linked to the issue have been reported.

The Volara system is a respiratory therapy device designed to provide oscillation and lung expansion (OLE) therapy. It is widely used in hospitals, long-term care facilities and home settings to help patients with respiratory conditions improve their lung function and airway clearance. The Volara single-patient use circuit is a crucial component of the system, intended to ensure that each patient receives clean and safe treatment.

Baxter said it is working with customers to replace the affected products.

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When the Volara system is used in-line with a ventilator and without a nebulizer connected to the blue ventilator adapter, the handset plug is needed to help ensure proper operation and ventilator gas flow. If the handset plug disconnects and goes unnoticed before or during therapy, it may lead to an interruption or delay of care, explained Baxter. This could lead to reduced ventilation and oxygenation due to gas flow leakage from the nebulizer port on the blue ventilator adapter.

Baxter has been grappling with recalls since last year. In May, the company issued an Urgent Medical Device Recall for its Life2000 Ventilator due to possible failure of the battery charging dongle. One injury associated with the defect has been reported, with no reports of deaths.

In November 2023, the US Food and Drug Administration (FDA) sent a Class I notice to Baxter for a correction to one of its drug delivery devices, the Novum IQ syringe pump, as opposed to a full-on product removal. The company sent affected customers an Urgent Medical Device Correction letter asking them to monitor fluid delivery to ensure proper dosing.

Baxter initiated a recall in September after discovering a software error in its Novum IQ syringe infusion pumps, which could cause the pumps to inaccurately indicate that an infusion had finished. Specifically, the error may cause the pumps’ software to miscalculate the remaining volume of a medication, blood or other fluid after it has detected a blockage, therefore determining an infusion to be complete before it actually is.

Recalls have been on the rise in the medical device industry. According to a report by technology-enabled risk, benefits and integrated business solutions provider Sedgwick, product withdrawals in the US medtech industry were at an all-time high in 2022, rising 8.8 percent to 911 in 2022, up from 837 the previous year. Moreover, total Class 1 recalls reached a 15-year high, increasing by 49 percent to 70 recalls in 2022, compared to an annual average of 47 recalls over the previous five years.

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