Z-1815-2015Class II

Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The...

Name: Z-1815-2015 Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The...
Creator: Integra LifeSciences Corp.
Published: 2015-05-27
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2015-05-27 / Terminated

FDA source

Integra LifeSciences Corp. began a recall of Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter... on 2015-05-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1815-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-27
Posted: 2015-06-18
Terminated: 2015-12-09
Recalling firm: Integra LifeSciences Corporation
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.
Product code: GWM Device, Monitoring, Intracranial Pressure
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.
FDA root cause: Under Investigation by firm
Action: Integra sent an Urgent Medical Device Recall letter dated May 27, 2015, to all customers who received 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. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to complete the customer response form and return it by email or fax to: [email protected] or FAX to 1-609-275-9445. Customers with any questions regarding the instructions are instructed to contact Customer Service at 1-888-601-0203. For questions regarding this recall call 609-936-6822.
Quantity in commerce: 1218 units
Distribution: Worldwide Distribution - US (Nationwide) and Internationally to ARGENTINA, BRAZIL, BULGARIA, CANADA, COLUMBIA, COSTA RICA, FRANCE, GERMANY, ITALY, MEXICO, GERMANY, ITALY, MEXICO, PANAMA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED ARAB EMIRATES, AND UNITED KINGDOM
Product codes and lots: 305000291459, 305000299228, 305000300396, 305000301413, 305000312261, 305000315716, 30500X294240, 30500X304371, 30500X309674, 30500X318076, 3050RX285879, 3050RY297365, 305E00318970, 305E0X320986

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1815-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1815-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-18

Product code GWM

K102875Class IICamino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post Craniotomy Subdural Pressure Monitoring Kit; CIntegra LifeSciences Corporation / cleared 2010-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)