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106 Microdialysis Pump
M DIALYSIS INC. · Model 106 · UDI-DI 07332699000034
10
510(k) clearances
6,877
Adverse events (82 deaths)
52
Recalls
68
Facilities
Description
Microdialysis pump running at a fixed flow rate of 0.3 µL/min for optimal Microdialysis sampling. The pump is prepared with the Battery (07332699000058) and the 106 Syringe (07332699000072) filled with the Perfusion Fluid (07332699000263) and finally connected to the Microdialysis catheter. The 106 Microdialysis Pump is easy to operate. An initial flush is performed automatically. Flushes can be initiated manually if necessary.
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.