A total of 23 imported devices issued voluntary recall notices from July to September 2023. Affected manufacturers include Medtronic, Siemens, Abbott, Covidien, Johnson & Johnson, etc. Many of these devices are not sold and used in China.
There are two Class I recalls which is the most urgent category:
- Abbott: Implantable Spinal Cord Neurostimulation System
Recall reason: The controller cannot establish communication with the implanted pulse generator (IPG) in MRI mode
- Covidien: Central venous catheter kit for hemodialysis
Recall reason: The silicone-based lubricant applied to the catheter tip was produced in an incorrect proportion, resulting in a thick coating that blocked the catheter tip
Complete List of Recalls July-September 2023
NMPA released the recall notices with intended use, impacted region, recall reason summary, corrective measures, etc. For more information on any devices below, please email info@ChinaMedDevice.com
- Medtronic: Avalus Bioprosthesis
- Medtronic: Endurant II Stent Graft System
- Medtronic: Sentrant Introducer Sheath
- Medtronic: spinal internal fixation system
- Medtronic: Navigation and positioning system tools
- Medtronic: Cranial surgery positioning equipment
- Medtronic: surgical power system
- Medtronic: Spinal neurostimulator doctor programmable system
- Medtronic: Patient programmer
- Medtronic: Neuromodulation equipment program controller
- Siemens: Diagnostic Ultrasound System
- Siemens: Digital Radiography X-ray System
- Siemens: Digital X-ray Radiography Fluoroscopy system
- Siemens: X-ray diagnostic system
- Abbott: Implantable Spinal Cord Neurostimulation System
- ArjoHuntleigh: Electric hospital bed
- Boston Scientific: radiofrequency ablation catheter
- Boston Scientific: subcutaneous implantable cardioverter defibrillator
- Covidien: Central venous catheter kit for hemodialysis
- Covidien: Sonicision Curved Jaw Cordless Ultrasonic Dissection System
- Edwards Lifesciences: floating catheter
- Johnson & Johnson: intraocular lens
- Johnson & Johnson: Synthetic absorbable surgical sutures
- Megadyne: Medical Products Reusable Patient Return Electrode
- MicroVention: SOFIA Distal Access Catheter
- Olympus: fiber uterine endoscope flexible hysteroscope
- Smith & Nephew: Total Knee System-Zirconium Niobium Alloy Femoral Condyle
- Smith & Nephew: Interlocking intramedullary nail system
- St. Jude Medical: Trifecta Valve with Glide Technology
- St. Jude Medical: bioprosthetic heart valve Trifecta Valve
- Thermo Fisher: RapID STR System
- Zimmer: Femoral handle
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- Source: https://chinameddevice.com/nmpa-recall-2023/
