The Recall Desk
SevereFDA (Devices)·Z-2071-2019·Announced 2019-08-14

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.

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 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.
Category
Medical Device — Implantable Cardioverter Defibrillator
Hazard
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.

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Same hazard · electrical failure

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