China NMPA Product Recall - Intra-aortic balloon catheters and accessories Sensation Plus

Datascope Corp., in collaboration with its local reporting entity Maikewei (Shanghai) Medical Equipment Co., Ltd., has initiated a voluntary Class II recall of its Sensation Plus Intra-Aortic Balloon Catheters and associated accessories. Announced by the National Medical Products Administration (NMPA) on July 14, 2023, this action addresses a significant product concern: the potential breakage of the guide dilator base during transsheath puncture procedures. This defect could compromise the device's performance and patient safety during critical medical interventions. The recall pertains to products covered under National Medical Device Registration Certificate No. 20223030475, involving specific models, specifications, and batches detailed in the Medical Device Recall Event Report Form. This measure reflects Datascope Corp.'s commitment to ensuring product integrity and patient well-being by proactively addressing identified hazards under NMPA oversight.