Reported Mar 4, 2020 · Terminated
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C…
St Jude Medical, Cardiac Rhythm Management Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St Jude Medical, Cardiac Rhythm Management Division · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- 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
- Lot codes and dates
274 of 274 codes
Serial #: 113840011384061138391113839311384031138366113838711383961138386113839911383741138362113836811383971138401113837211383751138382113838011384051138377113837111383901138398113836711383951138389113837911383701138388113836411383731138385113839411383811138404113839211383841138376113836911383651138465113862011385731138590113840711384081138409113841111384121138413113841511384161138417113841911384211138422113842311384241138429
- Amount recalled
- 256
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new St Jude Medical, Cardiac Rhythm Management… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.