St Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators
St Jude Medical is recalling 27 Ellipse VR implantable cardioverter defibrillators 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 where the failure to deliver high-voltage therapy poses a significant risk of serious injury or death to patients, meeting the criteria for a Severe rating.
Plain-English summary
St Jude Medical Inc. is recalling 27 units of the Ellipse VR implantable cardioverter defibrillator (ICD), reference CD1377-36C. The recall was initiated because electrical failures were identified in the devices due to damaged aluminum wires. These ICDs may contain electrical wire connections that are not completely insulated.
The potential patient impact of this defect is the inability of the device to deliver high-voltage therapy. The source text notes that there is no available option to verify the vulnerability status for devices that have already been implanted in patients.
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. Specific serial numbers for the 27 affected units are listed in the official recall documentation.
The recalled product
- Product
- ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 27
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: 9831140
- 9831656
- 9834078
- 9834079
- 9834084
- 9834177
- 9834184
- 9834187
- 9834307
- 9834319
- 9834322
- 9834323
- 9835098
- 9835106
- 9835107
- 9835351
- 9835354
- 9835356
- 9835768
- 9835769
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
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- SevereSt Jude Medical Recalls 47 Ellipse VR Implantable Cardioverter Defibrillators
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- SevereSt Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators
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- SevereSt Jude Medical Recalls Ellipse VR Cardioverter Defibrillators Due to Electrical Failures
FDA (Devices) · 2019-08-14
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Similar recalls
- SevereSt. Jude Medical Recalls Ellipse ICD Devices for Therapy Failure Risk
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- SevereSt Jude Medical Recalls Ellipse ICDs Due to High Voltage Capacitor Defect
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