The Recall Desk
HighFDA (Devices)·Z-2074-2019·Announced 2019-08-14

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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm medical device where the inability to deliver therapy could be life-threatening, but no injuries or illnesses have been reported in the source text.

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.
Category
Medical Device — Cardioverter/Defibrillator
Hazard
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

Same manufacturer · St Jude Medical Inc.

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Same hazard · electrical failure

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