The Recall Desk
SevereFDA (Devices)·Z-2075-2019·Announced 2019-08-14

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.

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 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.
Category
Medical Device — Cardioverter/Defibrillator
Hazard
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.

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Same hazard · electrical failure

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