Integra Camino Intracranial Pressure Monitoring Catheter with Licox… — Class II medical device recall Z-1815-2015
Terminated recall by Integra LifeSciences Corp., reported 2015-06-24, distributed nationwide. Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have
| Recall number | Z-1815-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2015-05-27 |
| Classified | 2015-06-18 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2015-12-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BG, BR, CA, CH, CR, DE, ES, FR, GB, IT, MX, PA, ZA |
| Quantity | 1,218 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00305000291459 |
| Model numbers | 110-4L |
Product
Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapidly determining and continuously monitoring intracranial pressure. The Camino catheter has a miniature transducer at the distal tip. This design eliminates the need for a fluid-filled system to carry pressure waves to an external transducer and thus, the problems inherent in such fluid-filled systems are eliminated. The Camino catheter is packaged with a zero adjustment tool which allows for the adjustment of the transducer during catheter preparation, and the LICOX Bolt Adapter Fitting. The Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt fitting, Model 110-4L is indicated for use by a qualified Neurosurgeon when direct measurement of intracranial pressure in the parenchyma is clinically important. It is intended to be used only through a Licox Brain Oxygen Monitoring System Bolt.
Reason for recall
Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Specifically, the o-ring in the bolt adapter may be in the wrong location and as a result, there is a potential CSF/blood could leak from the bolt adapter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1815-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.