St Jude Medical Recalls 42 Ellipse DR Cardioverter Defibrillators
St Jude Medical is recalling 42 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 recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves the inability to deliver life-saving high-voltage therapy, representing a significant risk of harm.
Plain-English summary
St Jude Medical Inc. is recalling 42 units of the ELLIPSE DR Tiered-therapy cardioverter/defibrillator (REF: CD2411-36Q) due to electrical failures caused by damaged aluminum wires. The recall covers devices distributed worldwide, including the United States and various countries in Europe, Asia, and the Middle East.
The electrical wire connections in these devices may not be completely insulated. This defect creates a potential risk that the implanted device may be unable to deliver high-voltage therapy when needed. There is currently no available option to verify the vulnerability status of these implanted devices.
Patients with these specific devices should contact their healthcare provider or St Jude Medical for further instructions. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 42
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 (20)
- Serial Number: 9829846
- 9829991
- 9830102
- 9830495
- 9830497
- 9831323
- 9831461
- 9831788
- 9831792
- 9831793
- 9831899
- 9831902
- 9833544
- 9833845
- 9833847
- 9833852
- 9833930
- 9834097
- 9834099
- 9834102
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
Same manufacturer · St Jude Medical Inc.
See all →- SevereSt Jude Medical Recalls 15 Ellipse DR Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 47 Ellipse VR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls Ellipse VR Cardioverter Defibrillators Due to Electrical Failures
FDA (Devices) · 2019-08-14
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