AESCULAP MINOP InVent 30 Trocar System recalled over laceration hazard

Recall date

March 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Aesculap Implant Systems LLC recalls AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for en…

Recall number

Z-1814-2017

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

Product was distributed throughout the United States and Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.