Home / Recalls / St. Jude Medical, Cardiac Rhythm Management Division / Z-0988-2022

Z-0988-2022 Class II Ongoing

Recalled by St. Jude Medical, Cardiac Rhythm Management Division — Sylmar, CA

Recall Details

Product Type
Devices
Report Date
April 27, 2022
Initiation Date
March 10, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

Reason for Recall

Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.

Code Information

REF# CDDRA500Q SN# 111018237, Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003

Other recalls by St. Jude Medical, Cardiac Rhythm Management Division

  • Z-1496-2022 Class II — Merlin 2 PCS MER37000 programmer Model MER3400 software (June 17, 2022)
  • Z-1495-2022 Class II — Merlin PCS 3650 programmer Model 3330 software (June 17, 2022)
  • Z-1497-2022 Class II — Merlin.net model MN5000 Software (June 17, 2022)
  • Z-0989-2022 Class II — Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q (March 10, 2022)
  • Z-0965-2022 Class II — Merlin 2 PCS MER3700 programmer Model MER3400 software (March 10, 2022)
  • Z-0990-2022 Class II — Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q (March 10, 2022)
  • Z-0964-2022 Class II — Merlin PCS 3650 programmer Model 3330 software (March 10, 2022)