Summary: Three major medical device manufacturers, Philips Respironics, Baxter Healthcare, and Zoll Medical, have issued recalls or corrections for their ventilators. The FDA classified these as Class I recalls, indicating the highest risk level. These recalls address critical issues that may cause serious injury or death.

Key Takeaways:

  • Philips Respironics recalled BiPAP ventilators due to a Ventilator Inoperative alarm failure, with 952 reported injuries and 65 deaths.
  • Baxter Healthcare addressed charging issues in Life2000 ventilators, instructing users to inspect and replace damaged battery charger dongles.
  • Zoll Medical updated MRI safety information for 731 ventilators to prevent misuse and potential ventilator failure, with no reported injuries or deaths.

Three more ventilators from major medical device manufacturers were issued recalls or corrections, joining several other serious recalls in the ventilator market.

Recent FDA Class I Recalls

The FDA recently classified ventilator recalls from Philips Respironics, Baxter Healthcare, and Zoll Medical as Class I recalls, the most serious type meaning that use of the device may cause serious injury or death. In the past year several major recalls have hit the ventilator market and one major manufacturer, Medtronic, even decided to exit the market entirely.

Philips Respironics Recall

Philips Respironics sent all affected customers an Urgent Medical Device Recall for its BiPAP V30, BiPAP A30, BiPAP A40 ventilators. The company is updating the use instructions for V30, A30, and A40 ventilators due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss.

These issues can result in therapy interruption or loss, potentially leading to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients. Philips recommended the following actions:

If a Ventilator Inoperative Alarm occurs, immediately remove the patient from the device and connect them to an alternate source of ventilation, if available.

As an optional step/action, an attempt to perform a “hard reboot” (forced device restart) that may temporarily restore device function, should be taken.

There have been 952 reported injuries. There have been 65 reports of death.

Baxter Healthcare Recall

Baxter Healthcare began notifying customers on May 29, via letter, about the potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage to the battery charger dongle prevents the ventilator’s internal battery from charging.

Patients, healthcare providers, wholesalers, and distributors were instructed to ensure patients always have an alternate means of ventilator or oxygen therapy available, inspect the battery charger dongle for damage and replace immediately if damaged. Patients may continue to use the ventilator system once they inspect and confirm no damage to the dongle and the battery is charging appropriately.

Patients were also asked to observe any alarms of the ventilator system and notify Baxter Home Care Customer Service for any assistance. Baxter will replace their ventilator device upon their next scheduled in-home visit with a clinical trainer, and patients were asked to acknowledge receipt of the letter.

Zoll Medical Corporation Recall

Zoll Medical Corporation is updating use instructions for 731 ventilators due to Magnetic Resonance Imaging (MRI) safety information in the labeling that may lead to misuse and ventilator failure.

The Operator’s Guide and Quick Reference Guide (QRG) include information on how far the ventilator should be placed from the MRI machine based on the magnetic field strength. However, a review found that some important details were accidentally left out of these guides. This missing information might lead users to place the ventilator too close to the MRI machine, which could cause the ventilator to trigger alarms, device malfunction, or unexpectedly shut down.

The use of affected products may cause serious adverse health consequences, including lack of oxygen, difficulty breathing, organ damage, and death.

There have been no reported injuries. There have been no reports of death.