Home / Recalls / St Jude Medical Inc. / Z-2070-2019

Z-2070-2019 Class I Terminated

Recalled by St Jude Medical Inc. — Sylmar, CA

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
June 20, 2019
Termination Date
April 3, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27

Product Description

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

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.

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

Code Information

Serial Number: 9831140, 9831656, 9834078, 9834079, 9834084, 9834177, 9834184, 9834187, 9834307, 9834319, 9834322, 9834323, 9835098, 9835106, 9835107, 9835351, 9835354, 9835356, 9835768, 9835769, 9835771, 9835914, 9835916, 9837174, 9837251, 9837256, 9837606

Other recalls by St Jude Medical Inc.

  • Z-2075-2019 Class I — ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 054 (June 20, 2019)
  • Z-2074-2019 Class I — ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 054 (June 20, 2019)
  • Z-2072-2019 Class I — ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 054 (June 20, 2019)
  • Z-2071-2019 Class I — ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) (June 20, 2019)
  • Z-2073-2019 Class I — ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) (June 20, 2019)
  • Z-2335-2018 Class II — Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) i (April 16, 2018)
  • Z-2318-2018 Class II — Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 6001 (April 16, 2018)
  • Z-2325-2018 Class II — Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-4 (April 16, 2018)
  • Z-2320-2018 Class II — Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981 (April 16, 2018)
  • Z-2324-2018 Class II — Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; C (April 16, 2018)