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Camino®

INTEGRA LIFESCIENCES (IRELAND) LIMITED · Model FLEXEXT · UDI-DI 10381780040965

GWM Prescription
1
510(k) clearances
6,858
Adverse events (82 deaths)
52
Recalls
68
Facilities

Description

The Integra Camino Flex Extension Cable is used to connect the Integra Camino Flex Catheter to the Integra Camino ICP Monitor. It is an eight foot long silicone cable, with circular PEI (polyetherimide) connectors and a Ferrite clamp on suppressor.

Recalls

DateFirmReason
2025-12-12Integra LifeSciences Corp. (NeuroSciences)Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
2025-12-12Integra LifeSciences Corp. (NeuroSciences)Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
2025-11-17SophysaCustomer complaints of Pressio monitor rebooting.
2024-11-01Medtronic NeurosurgeryDue to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
2024-11-01Medtronic NeurosurgeryDue to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
2024-09-24Smiths Medical ASD, Inc.Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak
2024-09-24Smiths Medical ASD, Inc.Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak
2024-04-09Sophysa S.A.An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could p
2024-04-09Sophysa S.A.An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could p
2023-10-05Integra LifeSciences Corp.Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a des

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.