Medtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks
Medtronic Neurosurgery recalls Becker External Drainage and Monitoring Systems due to reports of cracks and leaks in stopcocks. The recalled systems are used to drain cerebrospinal fluid and monitor pressure in neurosurgery patients.
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 medical device recall. Per the severity rubric, FDA Class I recalls must be scored at 4 or higher. While no illnesses or injuries are reported in the source, cracks and leaks in a cerebrospinal fluid drainage system create a significant risk of harm or device failure during neurosurgery.
Plain-English summary
Medtronic Neurosurgery is recalling the Becker External Drainage and Monitoring System (EDMS). The device is used to drain cerebrospinal fluid (CSF) from the lateral ventricles of the brain or lumbar subarachnoid space and to monitor CSF pressure and flow rate. Approximately 65,810 units are affected across 16 product configurations.
The FDA has classified this as a Class I recall. The recall is due to reports of cracks and leaks in the stopcocks associated with the device.
The affected units were distributed worldwide, including throughout the United States (including Puerto Rico), and to more than 80 countries. Specific product model numbers and lot numbers have been identified by the FDA.
Facilities and providers should contact Medtronic Neurosurgery for information regarding the recall and replacement of affected units.
The recalled product
- Product
- Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SI
- Manufacturer
- Medtronic Neurosurgery
- Hazard
- crack
- leak
- stopcock-defect
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27