St Jude Medical Inc. recalls ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)

Recall date

June 20, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2070-2019

FDA classification

Class I

Brand / firm

St Jude Medical Inc.

Sold / distributed

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

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)