Aesculap recalls specific brain ventricle implant systems (product code FF399R) due to trocar shaft length issues that may obscure the visual field when used with certain neuroendoscopes.
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.
Aesculap is recalling brain ventricle implant systems with product code FF399R because the trocar shaft is too long, which can obscure part of the visual field when used with a 30-degree neuroendoscope. This could lead to incomplete surgical visualization during brain procedures.
The trocar shaft is manufactured too long, causing part of the visual field to be obscured when used with a 30-degree neuroendoscope. This could lead to incomplete surgical visualization during brain procedures, potentially affecting surgical outcomes.
Surgical teams using the recalled implant systems for brain ventricle procedures are most at risk. Patients undergoing these specific surgeries may be affected if the wrong product is used.
Check for product code FF399R, serial numbers starting with 4281-4450, or lot numbers listed in the recall notice. These items were sold for brain ventricle procedures.
Check the product code (FF399R), serial numbers (4281-4450), or lot numbers (52750146, 52753381, etc.) to confirm if your item is recalled.
The trocar shaft is too long, which can obscure part of the visual field when used with a 30-degree neuroendoscope during brain ventricle procedures.
The recall does not specify a remedy, so check with the manufacturer for further instructions if you have the recalled product.
Look for product code FF399R, serial numbers starting with 4281-4450, or lot numbers listed in the recall notice (52750146, 52753381, etc.).
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-2518-2023 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-2518-2023 from Aesculap. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.