- Medtronic's Covidien unit has initiated a recall of Puritan Bennet 980 series ventilators due to a manufacturing error, marking the third Class I recall of the product since 2015.
- The recall was initiated due to a "manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use," according to an entry in the FDA recall database. The recall, which was initiated Nov. 4, affects 278 units.
- FDA has labeled the recall a Class I event, the most serious recall classification, but has not yet stated whether any reports of patient injuries or deaths have been tied to the product. In an emailed statement, the agency said that information could not be provided. Medtronic said in an emailed statement that one customer report of a device malfunction "indicated that, following the ventilator becoming inoperable while providing mechanical ventilation, the patient experienced cardio-respiratory complication, and passed away three days later."
The PB 980 series ventilators are used for pediatric and adult patients requiring respiratory support in hospitals settings, such as intensive care units and neonatal intensive care units, and for patient transport.
Medtronic acquired the ventilator series in its $42.9 billion purchase of Covidien in 2014. In 2015, Medtronic initiated a recall for over 650 units because the amount of air being delivered to patients could be lower than what was programmed, and in 2018, a recall was initiated to update software and address user interface issues.
The 2018 software update came after Australia suspended the supply of the devices for over one year. The Therapeutic Goods Administration, which is part of Australia's Department of Health, suspended supply of the devices after several reports of the screens going black, user interfaces not responding and unexpected shutdowns or restarts.
"This action has been taken as the TGA is concerned that, until rectified, use of these ventilators raises a potential risk of death, serious injury or illness," the regulator said in a September 2017 statement. The initial suspension was for six months; however, an additional six-month suspension was applied after a review of the product.
The TGA ultimately lifted the suspension in November 2018 with a list of conditions for Medtronic to adhere to, including updating the wording of warnings and instructions in user manuals.
After the most recent recall, Covidien asked physicians to immediately stop the use of the machines and quarantine the impacted units. According to the FDA database entry, the manufacturer has also requested that customers notify facilities or people of the recall if devices have been distributed to others.
Medtronic said that multiple reports of device malfunctions came in, which lead to an investigation and then the company's recall.
"This voluntary medical device correction was initiated following our investigation of six customer reports stating that a total of four ventilators became inoperable during use," the company said in the emailed statement. "The units included in the field corrective action were potentially affected by a manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly."
The possible assembly error affected devices manufactured between January 2017 and May 2018, and no devices currently being sold are impacted, according to the statement.
"As of Friday, November 12, 2021, all ventilators in-scope of this field corrective action in the U.S. market have been inspected and no devices were identified as having the reverse capacitor issue," the company said in the statement. "The inspections for the remaining units outside of the U.S. included in this field corrective action are nearing completion with 94% of remaining unit inspections complete as of December 9, 2021."
While FDA's database entry states that 278 units were impacted, Medtronic said a total of 284 units were part of the recall.
This article was updated to include a statement from Medtronic.