Z-2518-2023Class II

For intraventricular indications mainly used for operations within the brain ventricles

Name: Z-2518-2023 For intraventricular indications mainly used for operations within the brain ventricles
Creator: Aesculap Implant Systems LLC
Published: 2023-07-20
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2023-07-20 / Open, Classified / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R on 2023-07-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2518-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-20
Posted: 2023-09-06
Recalling firm: Aesculap Inc
Product: For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Product code: GWG Endoscope, Neurological
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 25 units
Distribution: US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2518-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2518-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-13	2023-09-06

Product code GWG

K983365Class IIAesculap Minop SystemAesculap, Inc. / cleared 1998-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)