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Camino®
INTEGRA LIFESCIENCES (IRELAND) LIMITED · Model FLEXADR · UDI-DI 10381780122012
GWM
Prescription
1
510(k) clearances
6,841
Adverse events (82 deaths)
52
Recalls
68
Facilities
Description
The Integra Camino Flex Adapter is designed as an accessory to connect the Integra Camino Flex Catheters (Integra LifeSciences Corporation) with the Camino Advanced Monitor (CAM01) for the direct and continuous measurement of intracranial pressure (ICP). It is a reusable device with an accessory holder which allows the Integra Camino Flex Adapter to be permanently attached to the Camino Advanced Monitor.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-12 | Integra 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. |
| 2025-12-12 | Integra 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. |
| 2025-11-17 | Sophysa | Customer complaints of Pressio monitor rebooting. |
| 2024-11-01 | Medtronic Neurosurgery | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). |
| 2024-11-01 | Medtronic Neurosurgery | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). |
| 2024-09-24 | Smiths 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 |
| 2024-09-24 | Smiths 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 |
| 2024-04-09 | Sophysa 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 |
| 2024-04-09 | Sophysa 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 |
| 2023-10-05 | Integra 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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Get your free API keyRead the docsData 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.