Company: St Jude Medical, Cardiac Rhythm Management Division
Date of Enforcement Report:3/3/2020
Class II

PRODUCT

Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330

• Recall Number: Z-1351-2020

REASON

Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.

RECALLING FIRM/MANUFACTURER

St Jude Medical, Cardiac Rhythm Management Division on 1/22/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

256

DISTRIBUTION

US Nationwide and International