FDAOctober 8, 2021device

Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

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

The hazard

Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.

What to do

FDA enforcement status: Terminated

Brands named

cook

UPCs

00827002192614

Recall history

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

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