Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse

FDA device recall Z-2572-2014 · posted 2014-09-03 · Terminated

Recall details

Recalling firm

St Jude Medical Cardiac Rhythm Management Division

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.

Action taken

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

Status

Terminated

Product code

LWS

Quantity affected

51,492 units (27,396 units in US)

Distribution

Worldwide Distribution: US (nationwide), Canada, Australia, New Zealand, Japan, EU, Middle East, Latin America, and Asia-Pacific.

Date initiated

2014-08-19

Date posted

2014-09-03

Date terminated

2015-10-08

Location

Sylmar, CA