China NMPA Product Recall - Intrathecal catheter, drug infusion system
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Medtronic Inc. initiated a voluntary Class III recall of specific intrathecal catheters and drug infusion systems, as announced by the National Medical Products Administration (NMPA) on July 31, 2025. The recall was prompted by an error in the product's electronic instruction manual, where an incorrect translation resulted in missing crucial information within the "Intended User" and "Storage" sections. Medtronic (Shanghai) Management Co., Ltd. reported this issue. It is important to note that the affected products involved in this recall were not imported into China. The regulatory action underscores the importance of accurate product documentation in ensuring patient safety and proper device usage. Further details regarding specific locations and batch numbers are available in the attached Medical Device Recall Event Report Form.
- Company
- Medtronic Inc.
ID · 3b512751-df4c-4390-a445-06bd88bab6c9