Home / Recalls / St Jude Medical Inc. / Z-0032-2018

Z-0032-2018 Class II Terminated

Recalled by St Jude Medical Inc. — Sylmar, CA

Recall Details

Product Type
Devices
Report Date
October 25, 2017
Initiation Date
August 28, 2017
Termination Date
July 8, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,453 units

Product Description

Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.

Reason for Recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Distribution Pattern

Worldwide Distribution

Code Information

Software version 23.1.1

Other recalls by St Jude Medical Inc.

  • Z-2071-2019 Class I — ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) (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-2070-2019 Class I — ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) (June 20, 2019)
  • Z-2075-2019 Class I — ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 054 (June 20, 2019)
  • Z-2073-2019 Class I — ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) (June 20, 2019)
  • Z-2334-2018 Class II — St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3 (April 16, 2018)
  • 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-2324-2018 Class II — Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; C (April 16, 2018)