FDA-Device2019-08-14Class I
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
St Jude Medical Inc.
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.
Sold states
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
Affected count
47
Manufactured in
15900 Valley View Ct, N/A, Sylmar, CA, United States
Products
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2071-2019Don't want to check this manually?
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