Medtronic Issues Class II Recall of Heart Suction Tube Due to Risk of Stylet Penetrating Catheter Tip

The National Medical Products Administration (NMPA) website recently published an announcement regarding Medtronic, Inc.'s voluntary recall of the Heart Suction Tube. Medtronic (Shanghai) Management Co., Ltd. recently reported that, due to issues involving specific models and batches, the guidewire-like probe of the Heart Suction Tube may penetrate the tip of the left heart vent tube. If this issue is not identified prior to surgery, the protruding guidewire-like probe may cause tissue damage. Consequently, the manufacturer, Medtronic, Inc., is voluntarily recalling the Heart Suction Tube (Registration Certificate No.: Imported Medical Device Registration No. 20152141672). The recall is classified as Class II.

The product subject to this recall is the cardiac vent drain. The registration certificate or filing record number is Imported Medical Device Registration Certificate No. 20152141672. The manufacturer is Medtronic, Inc., and the agent is Medtronic (Shanghai) Management Co., Ltd. The product is intended for venting the left heart during cardiac surgery, or for pericardial and cardiac drainage.

The recall was initiated because Medtronic, through complaint investigations, identified that the wire-like probe of the cardiac vent drainage catheter may protrude through the tip of the left heart vent catheter, with an occurrence rate of 0.0429%. If this issue is not identified prior to surgery, the protruding wire-like probe may cause tissue damage (abrasion/perforation), potentially resulting in prolonged surgical or surgical repair time. As of August 9, 2021, Medtronic has received 14 related complaints, 3 of which reported tissue damage or perforation requiring surgical repair. No other adverse events have been reported.

The affected regions and countries are global, the affected product model specifications are 12116 and 12118, the quantity of affected products manufactured in (or imported into) China is 0, the total quantity is 0, and the quantity of affected products sold in China is 0.

The affected products are not distributed in China, and no further corrective action is required.

According to a search by China Economic Net reporters, Medtronic ranked first on the 2020 Global Top 100 Medical Device Companies list, unchanged from its 2019 ranking, with revenue reaching USD 28.913 billion.