FDAFDA · Food and drugs·Recall number Z-2074-2019
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
Published August 14, 2019 · Recall initiated: June 20, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- St Jude Medical Inc.
- Distributor
- Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO
- Lot
- Serial Number: 9836058, 9836059, 9836061, 9836062, 9836063, 9836064, 9836065, 9836066, 9836067, 9836219, 9836220, 9836221, 9838312, 9838544, 9838546
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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