The Recall Desk
SevereFDA (Devices)·Z-2073-2019·Announced 2019-08-14

St Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators

St Jude Medical is recalling 21 Ellipse DR implantable cardioverter defibrillators 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 where the inability to deliver high-voltage therapy poses a significant risk of serious injury or death to patients with life-threatening arrhythmias.

Plain-English summary

St Jude Medical Inc. is recalling 21 units of the Ellipse DR implantable cardioverter defibrillator (ICD), reference number CD2377-36QC. The recall is due to electrical failures identified in the devices caused by damaged aluminum wires. These wires may not be completely insulated, creating a risk that the ICDs will be unable to deliver high-voltage therapy to patients.

The affected devices were distributed worldwide, including in the United States and various international markets. There is no available option to verify the vulnerability status of these devices once they have been implanted in patients. The specific serial numbers for the 21 recalled units are listed in the official recall documentation.

The recalled product

Product
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
Manufacturer
St Jude Medical Inc.
Category
Medical Device — Implantable Cardioverter Defibrillator
Hazard
Affected units
21

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: 1282011
  • 1282019
  • 1282065
  • 1282069
  • 1282424
  • 1282458
  • 1282469
  • 1282474
  • 1282596
  • 1282602
  • 1282609
  • 1282622
  • 1282625
  • 1282638
  • 1282641
  • 1282648
  • 9829389
  • 9831310
  • 9831509
  • 9831515

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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