Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter Recalled by EPIX THERAPEUTICS, INC Due to It has been identified that the catheter size...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact EPIX THERAPEUTICS, INC directly.
Affected Products
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
Quantity: 100 units
Why Was This Recalled?
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.
Where Was This Sold?
Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada
About EPIX THERAPEUTICS, INC
EPIX THERAPEUTICS, INC has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report