The Recall Desk
SevereFDA (Devices)·Z-2070-2019·Announced 2019-08-14

St Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators

St Jude Medical is recalling 27 Ellipse VR 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 failure to deliver high-voltage therapy poses a significant risk of serious injury or death to patients, meeting the criteria for a Severe rating.

Plain-English summary

St Jude Medical Inc. is recalling 27 units of the Ellipse VR implantable cardioverter defibrillator (ICD), reference CD1377-36C. The recall was initiated because electrical failures were identified in the devices due to damaged aluminum wires. These ICDs may contain electrical wire connections that are not completely insulated.

The potential patient impact of this defect is the inability of the device to deliver high-voltage therapy. The source text notes that there is no available option to verify the vulnerability status for devices that have already been implanted in patients.

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. Specific serial numbers for the 27 affected units are listed in the official recall documentation.

The recalled product

Product
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
Manufacturer
St Jude Medical Inc.
Category
Medical Device — Implantable Cardioverter Defibrillator
Hazard
Affected units
27

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: 9831140
  • 9831656
  • 9834078
  • 9834079
  • 9834084
  • 9834177
  • 9834184
  • 9834187
  • 9834307
  • 9834319
  • 9834322
  • 9834323
  • 9835098
  • 9835106
  • 9835107
  • 9835351
  • 9835354
  • 9835356
  • 9835768
  • 9835769

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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