China NMPA Product Recall - Adjustable catheter sheath

Medtronic CryoCath LP, a medical device manufacturer, through its reporting entity Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary Class II recall for its adjustable catheter sheaths (Registration Certificate No.: 20153772565). This significant action was publicly announced on November 26, 2018, and communicated through the National Medical Products Administration (NMPA), the regulatory body overseeing medical products. The critical issue prompting this recall is a higher-than-expected frequency of severe adverse events, specifically reports of patient death or coma, attributed to air embolism during ablation procedures involving the recalled product. The company's decision underscores its commitment to patient safety and compliance with established product surveillance standards. While no specific inspection dates are provided within the recall notice, the voluntary nature of the recall indicates a proactive response to identified safety concerns. Medtronic has mandated the recall of the affected adjustable catheter sheaths to prevent further patient harm. Comprehensive details pertaining to the precise models, specifications, and batch numbers of the products implicated in this recall are available in a supplemental document titled the "Medical Device Recall Event Report Form," which serves as the primary reference for all involved parties regarding the scope of the recall.