|
Early Alert: Compact Medical Removes and Updates Use Instructions for ButterflyBVM Bag-Valve-Mask Resuscitators
The FDA is aware that Compact Medical has issued an “Urgent Medical Device Recall” notice to affected customers recommending certain lots of ButterflyBVM Single-Use Bag-Valve-Mask (BVM) Resuscitators be removed from where they are used or sold. The notice also recommends updated use instructions (correction) for certain lots prior to continued use.
Compact Medical has reported the potential for a hole to form in the bellows of certain ButterflyBVM devices. Units from Lots 000109 through 000117 have a higher rate of holes in the bellows than previously observed.
If a hole develops in the bellows, tidal volume can leak from the device instead of reaching the patient. A leak in the bellows can cause inadequate ventilation and hypoxia. If not corrected, this could result in serious injury or death.
As of November 2, 2026, Compact Medical has reported no serious injuries or deaths associated with this issue.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Compact Medical at info@butterflybvm.com.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
|
