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FDAJuly 26, 2022device

Optima Coil System Model OPTI0520CSF10. For endovascular embolization.

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

The hazard

Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.

What to do

FDA enforcement status: Ongoing

Brands named

balt

UPCs

00818053026164

Recall history

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

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Optima Coil System Model OPTI0520CSF10. For endovascular embolization. — Recall Details · AllClear