FDAJanuary 19, 2021device
HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that when i...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.
What to do
FDA enforcement status: Terminated
Brands named
merit medical systemsmeritmerit medical
UPCs
00884450489345
Recall history
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