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St Jude Medical Inc. recalls ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
Recalled August 14, 2019 · FDA recall Z-2070-2019 · St Jude Medical
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. · FDA Class I
Units
27
Sold at
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
Description
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.
Product
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
Manufacturer(s)
St Jude Medical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →