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Braincare
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA · Model BcAc-AF-1000 · UDI-DI 07908398200220
GWM
Prescription
1
510(k) clearances
6,841
Adverse events (82 deaths)
52
Recalls
68
Facilities
Description
Headband 1 of Braincare Wirelss Non-Invasive Intracranial Pressure and Brain Compliance Monitoring System (Model: BcAc-AF-1000)
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.