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Recall Observatory FDA recall evidence

Device 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.

Z-1814-2017

March 07, 2017

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 76769
Status
Terminated
Classification
Class II
Quantity
21 units distributed in U.S.
Official record key
device-enforcement:Z-1814-2017

Official wording

Reason: 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.

Code information: Item # FH620R

Distribution pattern: Product was distributed throughout the United States and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.