medical Class II Updated 2021-04-07

EPIX THERAPEUTICS, INC recalls EPIX Therapeutics DiamondTemp Unidirectional Small Curve Abl

Recalled Product

EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198

Hazard / Issue

It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.

Issued by

FDA

Distribution: Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada
Lot/Code Info: All Lots
View official government recall

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