FDA-Device2021-04-07Class II
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006
EPIX THERAPEUTICS, INC
Hazard
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.
Sold states
Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada
Affected count
19 units
Manufactured in
945 Stewart Dr Ste 100, Sunnyvale, CA, United States
Products
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1321-2021Don't want to check this manually?
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