The Recall Desk
SevereFDA (Devices)·Z-2072-2019·Announced 2019-08-14

St Jude Medical Recalls Ellipse VR Cardioverter Defibrillators Due to Electrical Failures

St Jude Medical is recalling 52 Ellipse VR cardioverter defibrillators worldwide 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 involves a structural defect in a life-saving medical device (cardioverter/defibrillator) that could result in the inability to deliver therapy, meeting the criteria for a Severe (Score 4) classification due to significant injury risk.

Plain-English summary

St Jude Medical Inc. is recalling 52 units of the Ellipse VR Tiered-therapy cardioverter/defibrillator (REF: CD1411-36Q, UDI: 05414734507738). The recall is due to electrical failures identified in the devices caused by damaged aluminum wires. These devices may contain electrical wire connections that are not completely insulated.

The potential patient impact of this defect is the inability to deliver high-voltage therapy. There is no available option to verify the vulnerability status for implanted devices. The affected units were distributed worldwide, including the US nationwide and in specific countries such as Germany, France, Italy, Spain, and others.

Patients with these implanted devices should contact their healthcare provider or St Jude Medical for further instructions regarding the recall and potential replacement or repair options.

The recalled product

Product
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
Manufacturer
St Jude Medical Inc.
Category
Medical Device — Cardioverter/Defibrillator
Hazard
Affected units
52

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: 9828978
  • 9829577
  • 9830723
  • 9830869
  • 9831468
  • 9831616
  • 9831748
  • 9831795
  • 9831810
  • 9831919
  • 9833545
  • 9833546
  • 9834026
  • 9834051
  • 9834053
  • 9834055
  • 9834059
  • 9834063
  • 9834071
  • 9834140

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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