St. Jude Medical Recalls Ellipse ICD Devices for Therapy Failure Risk
St. Jude Medical is recalling 127 Ellipse ICD devices because they may fail to deliver high-voltage therapy needed to treat life-threatening heart rhythms.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class II medical device defect where the failure to deliver therapy could result in serious injury or death from untreated life-threatening arrhythmias, meeting the criteria for a Severe rating.
Plain-English summary
St. Jude Medical is recalling 127 units of the Ellipse ICD (Implantable Cardioverter Defibrillator) devices, specifically models CD2411-36Q, CD2411-36C, CD1411-36Q, and CD1411-36C. The recall is due to a potential inability of the devices to deliver high-voltage therapy, which is intended for the automated treatment of life-threatening ventricular arrhythmias.
The affected devices were distributed worldwide, including in the United States (Connecticut, New Jersey, South Carolina, Florida, and Georgia) and in numerous international locations such as Finland, France, Germany, Great Britain, Greece, Israel, Italy, Japan, Kuwait, Lebanon, Netherlands, Northern Ireland, Poland, Romania, Slovakia, Spain, Tunis, United Arab Emirates, and Vietnam. Specific serial numbers for the recalled units are listed in the official recall documentation.
Patients with these implanted devices should contact their healthcare provider or St. Jude Medical to discuss the recall and determine the appropriate next steps for their care. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the device could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening v
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 127
Distribution
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