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
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- Source: https://chinameddevice.com/nmpa-recall-2023/
- :is
- :not
- 2023
- 23
- a
- access
- affected
- Alloy
- an
- and
- any
- applied
- ARE
- below
- blocked
- cannot
- Category
- central
- China
- class
- COM
- Communication
- controller
- Devices
- diagnostic
- digital
- Doctor
- Electric
- equipment
- establish
- etc
- Ether (ETH)
- flexible
- floating
- For
- from
- generator
- Heart
- Hospital
- HTTPS
- i
- ii
- impacted
- in
- include
- information
- intended
- internal
- Issued
- Johnson
- jpg
- July
- kit
- List
- Manufacturers
- many
- measures
- medical
- more
- most
- MRI
- Navigation
- of
- on
- patient
- plato
- Plato Data Intelligence
- PlatoData
- please
- positioning
- power
- Produced
- Program
- programmable
- proportion
- pulse
- Quarter
- rapid
- reason
- region
- released
- resulting
- return
- reusable
- scientific
- September
- Siemens
- sold
- subcutaneous
- SUMMARY
- Surgery
- surgical
- synthetic
- system
- that
- The
- These
- Third
- tip
- to
- Total
- two
- Ultrasonic
- ultrasound
- urgent
- use
- used
- valve
- voluntary
- was
- which
- with
- x-ray
- zephyrnet