St Jude Medical Recalls 47 Ellipse VR Implantable Cardioverter Defibrillators
St Jude Medical is recalling 47 Ellipse VR ICDs worldwide due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
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 involves a Class I medical device defect that could result in the inability to deliver life-saving high-voltage therapy, meeting the criteria for a Severe rating due to significant injury risk.
Plain-English summary
St Jude Medical Inc. is recalling 47 units of the Ellipse VR implantable cardioverter defibrillator (ICD), reference CD1377-36QC. The recall is due to electrical failures identified in the devices caused by damaged aluminum wires. These ICDs may contain electrical wire connections that are not completely insulated.
The potential impact on patients is the inability of the device to deliver high-voltage therapy. There is no available option to verify the vulnerability status of these implanted devices. The affected units were distributed worldwide, including the United States and various countries in Europe, Asia, and the Middle East.
Patients with these specific devices should contact their healthcare provider for further instructions. The recall number is Z-2071-2019.
The recalled product
- Product
- ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 47
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: 1281828
- 1281840
- 1282688
- 1282724
- 1282734
- 1283113
- 1283627
- 1283633
- 1283634
- 1283639
- 1283641
- 1283643
- 1283646
- 1283648
- 1283656
- 1283657
- 1283659
- 1283660
- 1283672
- 1283680
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 42 Ellipse DR 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
Same hazard · electrical failure
See all →- High
- SevereJaguar Land Rover Recalls Vehicles for DC-DC Converter Defect
NHTSA · 2026-09-17
- High
- HighHalcore Recalls 2025-2026 Horton Ambulances Due to Touchscreen Failure
NHTSA · 2026-08-14
- HighMarion Recalls 2025 Pumper Fire Engines Due to Display Unit Failure
NHTSA · 2026-08-10
Similar recalls
- SevereSt Jude Medical Recalls Ellipse ICDs Due to High Voltage Capacitor Defect
FDA (Devices) · 2014-09-10
- SevereSt. Jude Medical Recalls Ellipse ICD Devices for Therapy Failure Risk
FDA (Devices) · 2016-05-18
- HighSt Jude Ellipse ICD Recall for Wireless Communication Loss
FDA (Devices) · 2020-03-04
- ModerateSt Jude Medical Recalls Ellipse ICDs for Security Firmware Update
FDA (Devices) · 2018-07-04
- CriticalSt Jude Medical Recalls Implantable Defibrillators Due to Battery Defect
FDA (Devices) · 2016-11-02
- SevereSt Jude Medical Recalls Fortify ICDs Due to Premature Battery Depletion
FDA (Devices) · 2017-10-18