medical Class I Updated 2019-08-14

St Jude Medical Inc. recalls ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF:

Recalled Product

ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Number: 9828978, 9829577, 9830723, 9830869, 9831468, 9831616, 9831748, 9831795, 9831810, 9831919, 9833545, 9833546, 9834026, 9834051, 9834053, 9834055, 9834059, 9834063, 9834071, 9834140, 9834145, 9834167, 9834171, 9834256, 9834258, 9834259, 9834262, 9834265, 9834271, 9834272, 9834274, 9834275, 9834277, 9834285, 9834289, 9834291, 9834296, 9834299, 9834301, 9834302, 9834329, 9834398, 9834403, 9834407, 9834409, 9834418, 9834422, 9834423, 9834428, 9834431, 9834432, 9834553
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