China NMPA Product Recall - pH detection system

The National Medical Products Administration (NMPA) published a recall notice on June 17, 2016, concerning pH Measurement Systems manufactured by Given Imaging, Inc., a company under Medtronic. This voluntary recall was prompted by patient reports of allergic reactions attributed to trace amounts of nickel in the device's stainless steel needle, a component inherent to its design. The systems, specifically models FGS-0312 and FGS-0313, are designed for measuring gastroesophageal pH. Globally, Medtronic received three reports of allergic reactions since 2009, out of over 427,000 systems sold, indicating an extremely low complaint rate of 0.0007%. As a proactive measure, Medtronic issued a global safety notice. The NMPA directed its provincial and municipal Food and Drug Administrations to strengthen supervision of this product. Critically, the affected pH measurement systems were not sold or imported into China. Consequently, no direct corrective actions were mandated within the Chinese market, as domestic patients were not impacted by this particular recall.