FDA recall Z-1322-2021

EPIX THERAPEUTICS, INC · Class II · device

Product

EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013

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.

Distribution

Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada

Key facts

Status: Ongoing
Initiation date: 2021-02-22
Report date: 2021-04-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2021