FDA recall Z-2426-2018

Product

Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Reason for recall

Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .

Distribution

Worldwide Distribution - US Nationwide and Canada

Key facts

Status

Terminated

Initiation date

2018-03-29

Report date

2018-07-18

Termination date

2020-07-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2426-2018