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FDAJuly 20, 2023device

For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

aesculap implant systemsaesculapaesculap implant

UPCs

04038653065547

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R — Recall Details · AllClear