FDA has categorized a software update to Medtronic's Puritan Bennett 980 (PB980) ventilator series as a Class I recall, the company announced Tuesday.
The software update, which Medtronic made available in September, is designed to address problems with the user interface that contributed to Australian regulators suspending supply of the device for 12 months.
Medtronic has faced fewer regulatory objections elsewhere and has received no reports of serious injuries or deaths related to the problems.
PB980 is a mechanical ventilator that supports the breathing of neonatal, pediatric and adult patients in acute and critical care clinical settings. That role makes the reliability of PB980 a potential life and death matter.
In September, Medtronic told users of the device about the MR5.4 software update it had designed to address reports of problems with the user interface and the labeling of scalar waveforms. This week, Medtronic revealed FDA has categorized its action as a Class I recall. Medtronic is installing the update during routine maintenance and advising people to continue using the ventilators.
Medtronic, which acquired PB980 in its takeover of Covidien, created the software update after the Therapeutic Goods Administration (TGA) of Australia hit it with regulatory restrictions.
TGA suspended supply of the ventilator for six months in September 2017 after receiving complaints about unexpected shutdowns, unresponsive interfaces, blank screens and other failings. Medtronic had patched the software in 2015 and 2016 to address the problems. However, TGA continued to receive incident reports and its own tests in 2017 found the devices posed "an unacceptable risk to patients."
At the end of the six-month suspension, TGA revoked its original decision but introduced a new block on supply of the devices. TGA put the new six-month supply suspension in place after concluding that the devices remained prone to interface reliability problems and certain data inaccuracies.
Medtronic finally gained clearance to resume supply following the conclusion of the second period of suspension. By then, Medtronic had produced the MR5.4 software update that it is now rolling out in other regions and agreed to nine conditions. The conditions include changes to the operating manual that address the risk of blank or unresponsive user interfaces.
With FDA ruling the problems raise the risk of serious adverse health consequences or death, the PB980 ventilator series has now been subject to four Class I recalls in as many years. In part, that record reflects the vital role of ventilators and the serious consequences of their malfunctions.