Medtronic, BIOTRONIK, and Two Other Medical Device Firms Issue Recalls in China

Feb 23, 2025 16:59 CST Updated 16:59

Covidien Healthcare

Medical Product Manufacturer

Medtronic

Medical Device Manufacturer

NMPA News: 4 Medical Device Companies Initiate Recalls

Beckman Coulter Commercial Enterprise (China) Co., Ltd. reported that due to the forced stop of the Z-axis tray holding motor causing fault alarms or delays in patient test result reports, the manufacturer Beckman Coulter, Inc. (USA) initiated a voluntary recall of its fully automatic chemiluminescence immunoassay analyzer DxI 9000 Access Immunoassay Analyzer (Imported Medical Device Registration No. 20242220249).Recall Level: Class II Recall.

Beckman Coulter Commercial Enterprise (China) Co., Ltd. reported that due to issues such as the product rinse turntable mixer being unable to rotate freely and subsystem communication failures, which led to delays in patient diagnosis or treatment, the manufacturer Beckman Coulter, Inc. (USA) initiated a voluntary recall of its fully automated chemiluminescence immunoassay analyzer, DxI 9000 Access Immunoassay Analyzer (Registration No.: Guo Med Reg In 20242220249).Recall level is Level 2 recall.

Covidien Healthcare International Trading (Shanghai) Co., Ltd. reported that due to the difficulty in disconnecting the sampling tube from the patient's tracheal intubation, Oridion Medical 1987 Ltd. voluntarily recalled its Microstream CO2 sampling lines (Registration No.: Guo Med Reg In 20182070157).Recall level is Level II recall.

Medtronic (Shanghai) Management Co., Ltd. reported that due to incorrect model and batch numbers on the product outer box label, the manufacturer, Medtronic, Inc., voluntarily recalled its single-use intracardiac diagnostic electrode catheters (Registration No.: Guo Medical Device Registration Approval 20163070401). The recall level is classified as a Level III recall.

BIOTRONIK(Beijing)Medical Device Limited reported that due to the inconsistency between the actual product size and the package labeling, the manufacturer BIOTRONIK AG has voluntarily recalled its Peripheral self-expanding Nitinol stent system (Registration No. 20153131894 of Imported Medical Devices in China). The recall level is Level III.

▲ Source of the Article：Medical Device R&D - Jiayu Testing Network, sourced from NMPA

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