Z-1814-2017Class II

AESCULAP MINOP InVent 30 Trocar System, non-sterile

Name: Z-1814-2017 AESCULAP MINOP InVent 30 Trocar System, non-sterile
Creator: Aesculap Implant Systems LLC
Published: 2017-03-07
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2017-03-07 / Terminated / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central... on 2017-03-07. FDA classified it as Class II and gives the reason as "Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1814-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-07
Posted: 2017-03-20
Terminated: 2018-02-16
Recalling firm: Aesculap Inc
Product: AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.
Product code: GWG Endoscope, Neurological
Reason for recall: Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On March 15, 2017, 16 facilities and 1 Sales Rep were sent an Urgent Medical Device Recall Notification letter. Letters were sent Fed-Ex overnight. Customers were asked to immediately discontinue use and quarantine the product. A Sales Representative will remove the affected product and return to Aesculap Inc.
Quantity in commerce: 21 units distributed in U.S.
Distribution: Product was distributed throughout the United States and Canada.
Product codes and lots: Item # FH620R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1814-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1814-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12

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)