medical-devices
Every record this desk has filed under medical-devices, newest first, each with the number of sources it can still show you.
FDA approved the first heart valve designed to grow with children, a surgically implanted pulmonary valve for pediatric patients with congenital pulmonary valve disease.
The FDA approved the Autus Size-Adjustable Valve on October 1 for children with congenital pulmonary valve disease. It is the first heart valve designed to be widened by balloon catheter as a child grows, from about 13 up to 22 millimeters, and the first valve approved in the U.S. with synthetic leaflets instead of animal tissue. The approval rests on a 62-patient study at 12 U.S. sites; the FDA says it may reduce, not eliminate, repeat open-heart surgeries, and the announcement does not say when the valve becomes available.
Also filed underhealthpediatricsfda-approvalcongenital-heart-disease
A cable inside React Health's VOCSN ventilators, machines used in homes as well as hospitals, can work loose after a hard knock such as a drop and make the machine reboot; the FDA's September 23 early alert covers every unit with serial number 112786 or higher, and the company's September 17 letter says to keep backup ventilation ready and run a checkout procedure after any drop.
The Food and Drug Administration issued an early alert on September 23 for React Health's VOCSN ventilators, which are used at home as well as in hospitals and in transport, for patients from children to adults weighing at least 5 kg. A cable inside the machine can come partly or fully unseated, and a hard knock such as a drop can cause it; the ventilator can then reboot and show recurring System Fault 10 alarms. A reboot during use would interrupt ventilation. The alert covers every VOCSN-series machine with serial number 112786 or higher. React Health's September 17 letter to customers says to keep backup ventilation working and ready, keep the machine on a flat, stable surface or in its roll stand or carry bag, run the manual's Checkout Procedure after any drop or impact, and not stop therapy without an alternative and a clinician's instruction. The company says no reboots during therapy have been reported and calls that risk remote; as of August 12, 2026, it had reported no serious injuries or deaths. Questions go to React Health at 844-698-6276.
Also filed underfdaventilatorshome-carecaregiverspatient-safety
The FDA has put Abiomed's removal of every Automated Impella Controller, the console that runs the Impella heart pump, in its most serious recall class; Abiomed has reported 37 serious injuries and three deaths associated with a failing sensor part, and hospitals may keep using the controllers until that part is replaced.
On September 24 the Food and Drug Administration said it had classified Abiomed's removal of its Automated Impella Controllers, the consoles that run the Impella heart pump, as a Class I recall, the most serious type. A part in the controller's purge pressure sensor assembly, the purge flag, can fail, so the controller stops recognizing the purge disc and raises a 'Purge Disc Disconnected' or 'Purge Disc not Detected' alarm. Clearing it can mean swapping the controller, which can delay the start of support or briefly interrupt it. As of August 17, Abiomed had reported 37 serious injuries and three deaths associated with the issue. Every controller worldwide is in scope, and FDA's three recall database entries together list 10,754 units, 7,005 of them in the United States. Hospitals may keep using them until Abiomed services them, and are told to switch to a backup controller if the alarm will not clear. Abiomed began the recall with letters on August 12. A separate FDA early alert, current as of September 23, lists 237 controller serial numbers needing hardware, firmware or software updates; no serious injuries or deaths were reported for that issue as of September 8.
Also filed underfdadevice-recallsheart-pumpabiomedhospitalspatient-safety
A record appears here because it carries medical-devices in its own frontmatter. If a record you expected is missing, it was filed under a different subject — the full list is on the topics index.