The FDA issued an update on the June 2021 recall of Philips Respironics ventilators, BiPAP and CPAP devices, reporting that there have been an additional 7,000+ medical device reports (MDRs) and 111 deaths reported for the period of July 1, 2023 through September 30, 2023.
According to the January 31st FDA update, since April 2021, the FDA has received more than 116,000 MDRs, including 561 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown.
Reports to the FDA:
| Dates | MDRs Received | Reports of Deaths in MDRs |
|---|---|---|
| April 1, 2021 – April 30, 2022 | >21,000 | 130* |
| May 1, 2022 – July 31, 2022 | >48,000 | 57* |
| August 1, 2022 – October 31, 2022 | >21,000 | 106* |
| November 1, 2022 – December 31, 2022 | >8,000 | 81* |
| January 1, 2023 – March 31, 2023 | >6,000 | 44* |
| April 1, 2023 – June 30, 2023 | >4,000 | 32 |
| July 1, 2023 – September 30, 2023 | >7,000 | 111 |
The original recall of these Philips devices was announced by the company in June 2021.
On January 26, 2024, Philips Respironics announced that it would end the sale of certain ventilators, BiPAP and CPAP devices (and more products), including some affected by the June 2021 recall and subsequent recalls.
Source: FDA
