# China NMPA Product Recall - Cerebrospinal fluid shunt and accessories, lumbosacral-abdominal shunt assembly

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/a4364485-9cd5-4ecc-a4fd-f084b281c26b/
Source feed: China

> China NMPA product recall for Cerebrospinal fluid shunt and accessories, lumbosacral-abdominal shunt assembly by Medtronic Inc. published April 05, 2017. Recall level: Level III. Medtronic (Shanghai) Management Co., Ltd., under the oversight of the National Medical Products Admi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. is voluntarily recalling cerebrospinal fluid shunt tubes and accessories, and lumbosacral-abdominal shunt tube assemblies.
- Company Name: Medtronic Inc.
- Publication Date: 2017-04-05
- Product Name: Cerebrospinal fluid shunt and accessories, lumbosacral-abdominal shunt assembly
- Recall Level: Level III
- Recall Reason: In extremely rare cases, the accumulation of biological debris within a pressure regulating valve can restrict the free rotation of the magnet inside the valve. When the magnet inside the valve is exposed to a 3.0T MRI, the magnet cannot rotate synchronously with the external magnetic field, and the valve poles will rotate in the opposite direction to the external magnetic field, potentially damaging the regulating mechanism.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic (Shanghai) Management Co., Ltd., under the oversight of the National Medical Products Administration (NMPA), initiated a voluntary Class III recall for specific Cerebrospinal Fluid Shunts and Accessories, and Lumbosacral-Abdominal Shunt Components. The NMPA notice, dated April 5, 2017, stems from an internal investigation by Medtronic, Inc., the manufacturer, following reports received between February 2015 and November 2016.

The core issue involves the potential for biological debris accumulation within the pressure regulating valve of the devices. In extremely rare instances (0.007% occurrence rate over two years), this debris can restrict the magnet's free rotation, potentially damaging the regulating mechanism when exposed to a 3.0 Tesla MRI or stronger magnetic fields. Five global reports cited discrepancies between pressure settings and radiographic readings, although no related illnesses, injuries, or patient deaths have been reported. This issue does not affect devices exposed to 1.5T magnetic fields.

As part of the corrective actions for this global recall, Medtronic is sending notification letters to customers. Users are advised that if difficulties arise during valve adjustment or setting readings, radiographic confirmation should be considered. Furthermore, if indicator tool readings contradict X-ray images, X-ray imaging should be prioritized for accurate assessment. The recall applies to all batch numbers of the affected product models.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/