Medtronic Issues Class I Recall for Duet External Drainage and Monitoring System Following Injuries to 15 Patients
Medtronic
Medical Device Manufacturer
Becker
Professional Nursing and Related Talent Acquisition Solutions Provider
Source: Siyu Medtech
Recently, the FDA issued a Class I recall for Medtronic's Duet External Drainage and Monitoring System catheter, which is the most serious type of recall.
This recall involves device brands Becker and Exacta, which are primarily used for the safe drainage of cerebrospinal fluid during surgical procedures. However, due to the potential for cracks and leaks in the devices, there are serious health risks, including cerebrospinal fluid loss, infection, and even death.
01
Duet External Drainage and Monitoring System (EDMS) is used for temporary cerebrospinal fluid (CSF) drainage or CSF sampling, suitable for the following populations:
Surgery for Open Thoracic Aortic Aneurysm (Open TAA) or Open Thoracoabdominal Aortic Aneurysm (Open TAAA).
Patients who have undergone TAA/TAAA repair surgery and developed symptoms such as paraplegia.
The system includes a green striped tube, stopcock, drip chamber, pressure scale, needle-free injection/CSF sampling point, and a detachable bag with measurement and vent.
The system works by gravity, allowing CSF to flow from the external lumbar catheter through the patient tube, into the drip chamber, and finally into the bag. It is recommended to use it with the separately provided Clear-Site laser level.
This recall was initiated after 15 patients were injured by the EDMS.
FDA Points Out That the Check Valve of EDMS May Have Cracks or Leaks, Which Could Lead to Cerebrospinal Fluid Leakage and Subsequent Complications Such as Infections. Although No Deaths Have Been Reported Currently, Due to the Potential for Serious Injury, the FDA Has Classified This Recall as a Class I Recall.
▲ Common Locations of Cracks
Medtronic Analyzes Cracks and Leaks in Becker and Exacta EDM Products: Over-tightening of the stopcock by doctors may cause cracks and leaks. Therefore, the FDA and Medtronic recommend that doctors avoid over-tightening and follow the instructions for inspection.
Prior to this, the FDA and NMPA respectively issued a Level 1 recall for Becker and Exacta EDM in November and December of last year, with over 210,000 units recalled in China.
This article is a reprint, all opinions belong to the original author.Platform(Siyu Medtech), Medical DevicesBusinessEvaluationDisclaimer: All viewpoints in the article are neutral and intended solely for sharing and discussion.
In order not to miss any content, everyone remembers toMedical Device Business ReviewSet as starred? Oh,
Looking forward to meeting you at the first moment every time
