Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Recall Z-2572-2014 · Posted 2014-09-03
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Recalling FirmSt Jude Medical Cardiac Rhythm Management Division
Recall StatusTerminated
Product CodeLWS
Date Initiated2014-08-19
Date Terminated2015-10-08
Product Quantity51,492 units (27,396 units in US)
Reason for Recall
An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. It may present as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert.
Firm Action
A customer letter dated 8/19/14 was sent to physicians with the affected Ellipse ICDs on 8/20/14. The letter identifies the problems and the actions to be taken.
Customers with any questions or concerns are instructed to contact their local St. Jude Medical representative or St. Jude Medicals Technical Services Department.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution: US (nationwide), Canada, Australia, New Zealand, Japan, EU, Middle East, Latin America, and Asia-Pacific.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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