FDA Device recall Z-2518-2023
For intraventricular indications mainly used for operations within the brain ventricles
- FDA Device
- Class II
- ongoing
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class II recall of For intraventricular indications mainly used for operations within the brain ventricles by Aesculap Implant Systems, citing trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is ob….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2518-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-20 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aesculap Implant Systems |
| Distribution | US |
Product
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Reason
Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
Identifiers
| code_info | UDI-DI: 04038653065547 Lot Numbers: 52750146 52753381, 52756472, 52768317, 52805655, 52812596, 52816570, 52823878, 5283…UDI-DI: 04038653065547 Lot Numbers: 52750146 52753381, 52756472, 52768317, 52805655, 52812596, 52816570, 52823878, 52830872. Serial Numbers: 4281,4282, 4284,4288, 4289,4291, 4308,4309, 4310, 4312, 4313,4336, 4340,4341, 4342,4402, 4411, 4412, 4413,4414, 4422,4439, 4447,4449, 4450 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2518-2023%22
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