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.
FDA Recall Z-1814-2017 · Posted 2017-03-20
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Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeGWG
Date Initiated2017-03-07
Date Terminated2018-02-16
Product Quantity21 units distributed in U.S.
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Product was distributed throughout the United States and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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