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Recall Observatory FDA recall evidence

Device product

ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)

Z-2073-2019

June 20, 2019

Class I

Product summary

Firm
St Jude Medical Inc.
Event
Event 83252
Status
Terminated
Classification
Class I
Quantity
21
Official record key
device-enforcement:Z-2073-2019

Official wording

Reason: 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.

Code information: Serial Number: 1282011, 1282019, 1282065, 1282069, 1282424, 1282458, 1282469, 1282474, 1282596, 1282602, 1282609, 1282622, 1282625, 1282638, 1282641, 1282648, 9829389, 9831310, 9831509, 9831515, 9831516

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.