For intraventricular indications mainly used for operations… recallZ-2518-2023 · Aesculap Implant Systems LLC · initiated Jul 20, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aesculap Implant Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process change control
What the company is doing
Aesculap issued Urgent Medical Device Recall Notification Letter via USPS Certified Mail 20.JUL.2023. Letter states reason for recall, health risk and action to take: 1. Review the Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and all concerned persons are informed about this voluntary product recall. 2. Your Aesculap Sales Representative will be in contact with you to review your current inventory, aid in evaluating your devices and assist you in completing the attached Product Acknowledgement Form. 3. Do not destroy any affected product. 4. Utilizing the attached form, you and your Sales Representative will record the total number of individual impacted pieces. If you have no inventory remaining, a zero (0) will be entered on the form. 5. Return the completed "Product Acknowledgement Form" to Aesculap, Inc. Product Quality Excellence department by emailing the form to [email protected] or faxing the form to (610) 849-1197 after your inventory has been evaluated by your Sales Representative, even if the total inventory in your possession is zero (0). 6. Once Aesculap, Inc. receives your "Product Acknowledgement Form", a customer support representative will contact you with instructions on how to return any impacted pieces in your possession.
Recall details
- Recall number
- Z-2518-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 20, 2023
- Posted by the FDA
- Sep 6, 2023
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 25 units
- Product code
- GWG
- FDA submissions
- K983365
- Distribution
- US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
Product description
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AESCULAP FF399RAesculap AG · ENDOSCOPE, NEUROLOGICAL2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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