St Jude Medical Recalls 15 Ellipse DR Cardioverter Defibrillators
St Jude Medical is recalling 15 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the…"
Plain-English summary
St Jude Medical Inc. is recalling 15 units of the ELLIPSE DR Tiered-therapy cardioverter/defibrillator (REF: CD2411-36C, UDI: 05414734507585). The recall is due to electrical failures identified in the devices caused by damaged aluminum wires. These wires may not be completely insulated, which could result in the device's inability to deliver high-voltage therapy to the patient.
The affected devices were distributed worldwide, including nationwide in the United States and in specific countries such as Germany, France, Italy, Spain, the Netherlands, Portugal, Sweden, Hungary, Denmark, Poland, Israel, Guadeloupe, Algeria, Switzerland, Saudi Arabia, Slovakia, Luxembourg, New Zealand, Vietnam, and Norway. The specific serial numbers affected are 9836058, 9836059, 9836061, 9836062, 9836063, 9836064, 9836065, 9836066, 9836067, 9836219, 9836220, 9836221, 9838312, 9838544, and 9838546.
There is no available option to verify the vulnerability status for implanted devices. Patients with these specific devices should contact their healthcare provider or St Jude Medical for further instructions regarding the recall and potential replacement or repair.
The recalled product
- Product
- ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Serial Number: 9836058
- 9836059
- 9836061
- 9836062
- 9836063
- 9836064
- 9836065
- 9836066
- 9836067
- 9836219
- 9836220
- 9836221
- 9838312
- 9838544
- 9838546
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by St Jude Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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