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

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/aff9cb95-0bf8-415a-8778-85cc5d1aec7f/
Source feed: China

> China NMPA product recall for Cerebrospinal fluid shunt and accessories, lumbosacral-abdominal shunt assembly by Medtronic Inc. published March 17, 2017. Recall level: Level III. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of its Cerebrospina

---

## 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: 2017-03-17
- Product Name: Cerebrospinal fluid shunt and accessories, lumbosacral-abdominal shunt assembly
- Recall Level: Level III
- Recall Reason: Between February 2015 and November 2016, Medtronic received five reports globally of discrepancies between pressure levels when valves were set on hand tools and readings determined by radiographic imaging. No related illnesses, injuries, or patient deaths were reported. The investigation found that, in extremely rare cases, the accumulation of biodebris within pressure regulating valves can restrict the free rotation of magnets within the valve. When the magnets within the valves are exposed to a 3.0T MRI (or a stronger magnetic field), the magnets cannot rotate synchronously with the external magnetic field, and their poles will be opposite to the external magnetic field; health hazard analysis showed that the probability of polarity reversal in the magnets within the valves is very low (occurrence rate over the past two years (0.007%)). 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 of its Cerebrospinal Fluid Shunt and Accessories, and Lumbosacral-Abdominal Shunt Assembly. This action, reported to the National Medical Products Administration (NMPA) on February 20, 2017, and publicly noted on March 17, 2017, falls under NMPA Index No. JGXX-2017-10251.

The recall stems from an investigation prompted by five global reports received between February 2015 and November 2016. The company found that, in rare instances, biological debris accumulation within the pressure regulating valve could impede the internal magnet's rotation. When exposed to a 3.0 Tesla MRI or stronger magnetic fields, this obstruction might prevent accurate adjustment and potentially damage the regulating mechanism, leading to discrepancies between hand tool settings and radiographic readings. Importantly, no patient illnesses, injuries, or deaths have been reported.

As required actions, Medtronic is issuing notification letters to customers. Healthcare providers are advised that if any difficulties arise in adjusting or reading valve settings, radiographic imaging must be used to confirm accurate device placement and settings. This ensures proper device functionality and patient care in accordance with medical device regulations.

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