Medtronic Inc. Announces Voluntary Recall of Spinal Cord Stimulator Clinician Programmer System and Lumbar External Drainage and Monitoring System
Medtronic
Chronic Disease Medical Device and Therapy Developer
China Finance Online, December 21 – Today, the National Medical Products Administration issued an announcement stating that Medtronic Inc. is voluntarily recalling its Spinal Cord Stimulator Physician Programming System (Registration Certificate No.: Guo Xie Zhu Jin 20202120339) and Lumbar External Drainage and Monitoring System (Registration Certificate No.: Guo Xie Zhu Jin 20173660162).
Among them, due to software issues affecting specific models and batches of products, which prevented users from further upgrading the devices, a voluntary recall was initiated for the Spinal Cord Stimulator Physician Programmer System (Registration Certificate No.: Guo Xie Zhu Jin 20202120339). The recall is classified as Class II, and the number of units sold in China is 0.
Due to the sale of specific models and batches of products in Singapore and South Korea without local regulatory approval, a voluntary recall has been initiated for the Lumbar External Drainage and Monitoring System (Registration Certificate No.: Guo Xie Zhu Jin 20173660162). The recall is classified as Class III, and the number of units involved in sales within China is zero.
