Exacta External Drainage System Stopcocks May Leak or Crack
Medtronic Neurosurgery is recalling Exacta External Drainage and Monitoring Systems worldwide due to complaints of cracking and leaking stopcocks. These components control cerebrospinal fluid drainage and intracranial pressure monitoring.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, indicating a reasonable probability of serious adverse health consequences. The stopcocks regulate critical neurosurgical functions; their failure could prevent proper brain fluid drainage or pressure monitoring, both essential for patient safety.
Plain-English summary
Medtronic Neurosurgery is recalling the Exacta External Drainage and Monitoring System (EDMS) and related components worldwide. The recall affects eight product variants, including kits and drainage bags, distributed across the United States and more than 60 countries. A total of 258,367 units have been distributed.
The recall was initiated due to complaints reporting that the stopcocks (control valves) on these systems are cracking and leaking. These stopcocks are critical components that regulate the drainage of cerebrospinal fluid (CSF) and monitor intracranial pressure (ICP) in neurosurgical patients. Cracks and leaks could prevent proper CSF drainage or disrupt pressure monitoring, compromising essential medical care.
Affected patients and healthcare providers should immediately discontinue use of recalled products and contact Medtronic Neurosurgery for further instructions. Patients currently relying on these systems should consult with their healthcare provider to arrange alternative drainage and monitoring methods. The U.S. Food and Drug Administration has classified this as a Class I recall, the most serious classification.
The recalled product
- Product
- Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS
- Manufacturer
- Medtronic Neurosurgery
- Hazard
- stopcock-failure
- leak
Distribution
Distributed nationwide across the United States.
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