Actualizaciones regulatorias

Abbott has revised the instructions for use of its Amplatzer Amulet left atrial appendage occluder to specifically contraindicate placement near the pulmonary artery and added guidance on distance assessment.

The UDI label for model p7924a13 incorrectly lists a 40‑inch surface, while the approved configuration is a 36‑inch surface, risking incompatibility with bed frames.

Cardinal Health reports a Stryker recall of the StrykeFlow PS device due to multiple complaints of handpiece leakage during use.

Edwards reports mislabelled sensor cables on the ForeSight™ Oximeter Cable may cause swapped left/right StO2 values, risking misdiagnosis.