China NMPA Product Recall - Rapid exchange balloon dilation catheter

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of its Rapid Exchange Balloon Dilatation Catheter, as reported by the National Medical Products Administration (NMPA) on September 4, 2019. Between May and August 2019, Medtronic received complaints regarding difficulties in removing the protective wire, an external accessory for the Euphora balloon. The core issue stemmed from the use of an oversized protective wire in certain batches, leading to an insufficient gap or tight wrapping with the balloon tip lumen. This design flaw could cause significant difficulty in removing the protective wire prior to use. If excessive force is applied during removal, there is a risk of damaging the balloon tip or body. Such damage could subsequently lead to challenges with balloon inflation and de-inflation, prolonging surgical procedures and potentially causing vascular harm to patients. The recall was issued under the oversight of the Shanghai Food and Drug Administration, necessitating the identification and appropriate management of affected product models and batches, as detailed in the accompanying Medical Device Recall Event Report Form.