Recall Z-1320-2021— EPIX THERAPEUTICS, INC

Name: FDA recall Z-1320-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-22

Class II · Ongoing

Class II FDA medical device recall by EPIX THERAPEUTICS, INC, initiated 2021-02-22. FDA's recall record names no specific 510(k) clearance for this event. Product: EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303. Reason: 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..

Recalling firm: EPIX THERAPEUTICS, INC
Classification: Class II
Status: Ongoing
Initiated: 2021-02-22
Firm location: Sunnyvale, CA, United States

Product description

EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.