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FDAFebruary 1, 2019device

Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.

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

The hazard

The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.

What to do

FDA enforcement status: Terminated

Brands named

cook

Recall history

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

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