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Recall Observatory FDA recall evidence

Device product

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.

Z-2173-2026

April 10, 2026

Class II

Product summary

Firm
Integra LifeSciences Corp. (NeuroSciences)
Event
Event 98752
Status
Ongoing
Classification
Class II
Quantity
40 packs (200 units)
Official record key
device-enforcement:Z-2173-2026

Official wording

Reason: Out-of-specification endotoxin result that did not meet the acceptance criteria.

Code information: Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.

Distribution pattern: 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).

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification