St Jude Medical Recalls Ellipse ICDs Due to High Voltage Capacitor Defect
St Jude Medical is recalling Ellipse ICDs because internal capacitor damage may delay or prevent high voltage therapy delivery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a defect in a life-sustaining medical device (ICD) that may prevent the delivery of high voltage therapy, posing a significant risk of serious injury or death.
Plain-English summary
St Jude Medical Cardiac Rhythm Management Division is recalling specific models of Ellipse and Ellipse ST Implantable Cardioverter Defibrillators (ICDs). The recall affects 51,492 units worldwide, including 27,396 units in the United States. The affected models include CD1275, CD1311, CD2275, CD2311, CD1411, CD2411, CD1273, CD1309, CD1409, CD2273, CD2309, and CD2409.
The recall is due to a potential anomaly involving internal damage to the high voltage capacitors. This damage may result in delayed, partial, or no delivery of high voltage therapy and can cause extended charge times during capacitor maintenance or charging. The issue may present as a vibratory patient notification or as an alert on a programmer or Merlin.net system upon interrogation.
Patients with these devices should contact their healthcare provider or St Jude Medical to determine if their specific device is affected and to discuss appropriate monitoring or replacement options. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- 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.
Distribution
Distributed nationwide across the United States.
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