Home/Recalls/FDA-Z-2173-2026
FDA DevicesClass II

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.

Published: May 20, 2026Recall ID: Z-2173-2026Category: devicesCountry: US
US
Medical DeviceFDA DevicesUSUS

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.

Recalling Firm: Integra LifeSciences Corp. (NeuroSciences)

Reason for Recall / Hazard

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

Product Description & Identification

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.

Affected Products

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.

Additional Source Details

FieldValue
CityPrinceton
StateNJ
Event id98752
Address 11100 Campus Rd
Code infoProduct ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.
Postal code08540-6650
Report date20260520
Product typeDevices
Product quantity40 packs (200 units)
Reason for recallOut-of-specification endotoxin result that did not meet the acceptance criteria.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260410
Initial firm notificationLetter
Center classification date20260513

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Overview

  • Recalling FirmIntegra LifeSciences Corp. (NeuroSciences)
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS 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).
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: 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.

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https://therecallfile.com/recalls/codman-cerebroflo-evd-catheter-with-endexo-technology-contains-5-sets/FDA-Z-2173-2026
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Spread the WordCodman 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.

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