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St Jude Medical Cardiac Rhythm Management Division recalls Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ell
Recalled September 10, 2014 · FDA recall Z-2572-2014 · St Jude Medical Cardiac Rhythm Management Division
Hazard
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. · FDA Class II
Units
51,492 units (27,396 units in US)
Sold at
Worldwide Distribution: US (nationwide), Canada, Australia, New Zealand, Japan, EU, Middle East, Latin America, and Asia-Pacific.
Description
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.
Product
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.
Manufacturer(s)
St Jude Medical Cardiac Rhythm Management Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →