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

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.