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

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/00a82dba-9edc-486e-b060-d801f00e4593/
Source feed: China

> China NMPA product recall for Cerebrospinal fluid shunt and accessories, lumbosacral-abdominal shunt assembly by Medtronic Inc. published April 06, 2017. Recall level: Level III. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall for specific models

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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: 2017-04-06
- Product Name: Cerebrospinal fluid shunt and accessories, lumbosacral-abdominal shunt assembly
- Recall Level: Level III
- Recall Reason: Medtronic initiated this recall because, between February 2015 and November 2016, it received five reports globally of discrepancies between pressure levels on hand tools and readings determined by radiographic imaging. No related illnesses, injuries, or deaths were reported. The investigation found that, in extremely rare cases, the accumulation of biodebris within the pressure regulating valve could restrict the free rotation of the magnet inside the valve. When the magnet inside the valve is exposed to a 3.0T MRI (or a stronger magnetic field), the magnet cannot rotate synchronously with the external magnetic field, and the magnetic poles will be opposite to the external magnetic field; health hazard analysis shows that the probability of polarity reversal in the magnet within the valve is very low (an incidence of 0.007% over the past two years). Furthermore, this does not occur under a 1.5T magnetic field.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall for specific models of its Cerebrospinal Fluid Shunts and Accessories, and Lumbosacral-peritoneal shunt assemblies. This action, reported to the National Medical Products Administration (NMPA) on February 20, 2017, and published on April 6, 2017, addresses a manufacturing issue impacting products globally. The problem was identified through an investigation following five global reports between February 2015 and November 2016. The core issue involves the accumulation of biological debris within the pressure regulating valve, which can restrict the free rotation of an internal magnet. When exposed to a 3.0 Tesla MRI or stronger magnetic fields, this restriction can prevent the magnet from synchronizing with the external field, potentially damaging the regulating mechanism. Although no patient illnesses, injuries, or deaths have been reported, this could lead to discrepancies between device settings indicated by hand tools and those determined by radiographic imaging. Medtronic's required actions include notifying customers of this issue. Healthcare professionals are advised to utilize radiographic imaging to confirm valve settings if any adjustment or reading difficulties are encountered. If readings from indicator tools conflict with radiographic images, radiographic imaging must be used to ascertain the accurate valve placement.

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