St Jude Medical Inc.: Medical Device Recall in 2019 - (Recall #: Z-2072-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: June 20, 2019

Date Posted: August 14, 2019

Recall Number: Z-2072-2019

Event ID: 83252

Reason for Recall:

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.

Status: Terminated

Product Quantity: 52

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated