Recall Z-2173-2026 ยท JXG Shunt, Central Nervous System And Components
Integra LifeSciences Corp. (NeuroSciences)
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip.
| Date | May 13, 2026 (initiated Apr 10, 2026) |
| Status | Open, Classified |
| Reason | Out-of-specification endotoxin result that did not meet the acceptance criteria. |
| Root cause | Process control |
| Action | Integra notified consignees on about 04/10/2026 via letter. Consignees at medical facilities were instructed to examine inventory for affected units, remove them immediately from service and quarantine them, forward the notification to those who utilize the product so they are aware of the recall and can identify any affected product that may remain in clinical areas, and complete and return the "Medical Facility Acknowledgement Form provided. Integra Customer Care will contact consignees who have noted affected product on hand and provide a Return Material Authorization (RMA) number and direc |
| Quantity | 40 packs (200 units) |
| Distribution | US Nationwide distribution in the states of Arizona (AZ), Arkansas (AR), California (CA), Connecticut (CT), Florida (FL), Kentucky (KY), Louisiana (LA), Michigan (MI), Minnesota (MN), Missouri (MO), North Carolina (NC), North Dakota (ND), Oklahoma (OK), Oregon (OR), Texas (TX), Washington (WA). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170599 | SureFlo EVD Catheter Arkis Biosciences, Inc., Aug 31, 2017 |