Just as Philips began plotting out its recovery from the Class I ventilator recall it’s been grappling with for the better part of a year, it was hit with another curveball.
The Dutch devicemaker has expanded its recall yet again, though this time only by just a few hundred respiratory devices and repair kits—a far cry from the millions more it tacked on earlier this year.
A few weeks after Philips issued a recall for the latest group of devices in December, the FDA on Wednesday handed down another Class I rating to the company, indicating a heightened risk of serious injury or death linked to the affected devices.
The recalls stem from issues with the polyester-based polyurethane foam that was used in some of Philips’ respiratory devices to muffle sound. The foam was found to break down over time, potentially releasing black debris and other dangerous chemicals into a user’s airflow.
The new recall concerns certain Trilogy Evo ventilators and associated repair kits that were manufactured and distributed during the month between April 15 and May 24 of last year, after the foam issue had already been identified. The Trilogy Evo devices, used for pediatric and adult patients, weren’t included in the original recall, though the Trilogy 100 and 200 models were.
According to the recall notice, due to a mix-up by a Philips supplier, some Trilogy Evo models and their repair kits were equipped with the foam after it had been discontinued. The mistake was identified in lab tests of the devices, and Philips initiated the recall Dec. 21.
The affected models were distributed in the U.S. and Korea during that one-month period. A total of 473 ventilators and 205 repair kits are included in the recall, with 215 devices and 51 repair kits sent to U.S. users. No injuries or deaths related to these specific devices have been reported to Philips or the FDA.
The company said it will send replacement Trilogy Evo ventilators to all affected customers. In the meantime, however, healthcare providers and patients are advised not to stop using the devices. Instead, they should thoroughly clean them per Philips’ instructions and keep a close eye on the ventilators’ bacteria filters to spot any signs of debris from the foam.
Philips has faced plenty of obstacles since initiating the original recall in mid-June. For one, even after it was given the go-ahead from the FDA to begin a repair-and-replace program for the ventilators in September, the agency identified a potential issue with the replacement material for the polyurethane foam.
During an inspection of one of Philips’ manufacturing facilities, the FDA said in November, it was shown test results demonstrating that one device equipped with the new silicone-based foam had failed a safety test looking at whether volatile compounds were being released within the device.
Those results were confined to just one device that’s available only outside the U.S., and the FDA said at the time that it didn’t yet have enough information to overhaul its previous ruling on the new material’s safety, but would continue working with Philips to test the replacement foam.