Medtronic's Covidien faces another Class I recall of beleaguered Puritan Bennett ventilators

When it put down a casual $43 billion to merge with Covidien in 2015, Medtronic inherited its Irish partner’s Dublin headquarters and wide range of medical devices—and, consequently, any and all of their accompanying safety issues.

Throughout that time, perhaps the most troublesome of the acquired devices has been the 980 series of Covidien’s Puritan Bennett continuous ventilators. The respiratory machines have been the cause of a trio of Class I recalls since they were folded into Medtronic’s portfolio, the latest of which was initiated by the company in November and given the FDA’s most serious rating this week.

The recall spans a total of 278 ventilators that have been distributed around the world, per the FDA notice. It’s linked to an error in the devices’ manufacturing assembly in which a capacitor in the ventilators is incorrectly assembled, potentially causing the devices to stop working mid-use.

The FDA didn’t list the number of complaints that have been made to the agency regarding the manufacturing error, nor did it note whether any injuries or deaths have been linked to the issue.

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Medtronic sent an urgent medical device correction letter to all affected customers starting Nov. 4. The following day, the medtech giant’s technical service team began contacting those customers to schedule appointments to repair the ventilators included in the recall.

In the meantime, until the repairs are complete, healthcare providers are advised to immediately stop using their Puritan Bennett 980 ventilators. The devices should be quarantined, per Medtronic, with all clinicians who may come into contact with the machines notified about the manufacturing defect to prevent further use.

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This recall is the third Class I event tied to the 980 series of Covidien’s respiratory devices since the Medtronic acquisition, and the fifth overall since they received the FDA’s 510(k) clearance in 2014.

The ventilators are designed to adapt to each patient to help them return to breathing on their own as quickly as possible. The system is housed on a wheeled cart for easy access throughout the intensive care unit and is equipped with a touchscreen monitor, allowing clinicians to easily access patient monitoring data and navigate software controlling the amount of breathing support provided.

In 2018, Medtronic began a voluntary corrective action for more than 9,500 of the ventilators in use worldwide. The FDA doled out another Class I label for the action, which saw Medtronic install a software update on the devices to improve their external USB drive’s performance and effects on the touchscreen’s functionality and labeling.

That recall, which was completed in February of this year, was preceded by a year-long Class I recall that began in July 2015, just a few months after the devices had joined the Medtronic family. In that case, more than 650 units had to be reconfigured following reports that they could potentially deliver lower volumes of air to patients than what had been programmed into the machines.