CAS deadlines
Action underway: 23 September 2014, action complete: 17 November 2014
EllipseTM VR/DR implantable cardioverter defibrillators (ICDs).
Model numbers CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C and -36QC suffixes). All serial numbers distributed before the field action.
Manufactured by St Jude Medical.
PROBLEM:
Potential for delayed or insufficient energy defibrillation therapy due to a capacitor fault.
St Jude Medical issued a FSN dated 19 August 2014, describing a potential failure mode which can delay or reduce the therapy that can be delivered by the ICD. The problem has been traced to an ICD capacitor defect, accompanied in some returned devices with evidence of arcing between the capacitor anode and cathode. Analysis so far indicates that it is not possible to predict which ICDs will suffer this failure or when it may occur, so despite a low failure rate of 0.42%, all patients and clinicians will need to be vigilant.
All affected ICDs will exhibit extended charge times, evident not only during device testing / maintenance but also when preparing to deliver therapy. To date all potential failures reported to St Jude Medical have been identified through timeout warnings triggered by automated capacitor maintenance or during in-clinic testing, rather than being associated with serious adverse events.
The manufacturer has confirmed that all affected ICDs should now have been retrieved from hospital supplies and they are currently replacing them with newly designed product not expected to be susceptible to this failure mode. Replacement product can be identified according to the serial numbers detailed at the end of the FSN, and by the green label fixed to the ICD packaging.
For Detailed Information on Recall CLICK HERE
Action underway: 23 September 2014, action complete: 17 November 2014
EllipseTM VR/DR implantable cardioverter defibrillators (ICDs).
Model numbers CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C and -36QC suffixes). All serial numbers distributed before the field action.
Manufactured by St Jude Medical.
PROBLEM:
Potential for delayed or insufficient energy defibrillation therapy due to a capacitor fault.
St Jude Medical issued a FSN dated 19 August 2014, describing a potential failure mode which can delay or reduce the therapy that can be delivered by the ICD. The problem has been traced to an ICD capacitor defect, accompanied in some returned devices with evidence of arcing between the capacitor anode and cathode. Analysis so far indicates that it is not possible to predict which ICDs will suffer this failure or when it may occur, so despite a low failure rate of 0.42%, all patients and clinicians will need to be vigilant.
All affected ICDs will exhibit extended charge times, evident not only during device testing / maintenance but also when preparing to deliver therapy. To date all potential failures reported to St Jude Medical have been identified through timeout warnings triggered by automated capacitor maintenance or during in-clinic testing, rather than being associated with serious adverse events.
The manufacturer has confirmed that all affected ICDs should now have been retrieved from hospital supplies and they are currently replacing them with newly designed product not expected to be susceptible to this failure mode. Replacement product can be identified according to the serial numbers detailed at the end of the FSN, and by the green label fixed to the ICD packaging.
For Detailed Information on Recall CLICK HERE
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