Recall Z-2572-2014— 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 2014-08-19, terminated 2015-10-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- St Jude Medical Cardiac Rhythm Management Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-19
- Terminated
- 2015-10-08
- Firm location
- Sylmar, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.