Recall Z-1351-2020— St Jude Medical, Cardiac Rhythm Management Division
Class II · Terminated
Class II FDA medical device recall by St Jude Medical, Cardiac Rhythm Management Division, initiated 2020-01-22, terminated 2020-12-17. FDA's recall record names no specific 510(k) clearance for this event. 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. 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
- St Jude Medical, Cardiac Rhythm Management Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-22
- Terminated
- 2020-12-17
- Firm location
- Sylmar, CA, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.