Home / Recalls / Abbott Medical / Z-0552-2025

Z-0552-2025 Class III Ongoing

Recalled by Abbott Medical — Sylmar, CA

FDA device recall Z-0552-2025 was initiated by Abbott Medical on October 1, 2024 and is designated Class III. Reason for recall: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download. The recall status is ongoing. Affected quantity: Pending.

Recall Details

Product Type
Devices
Report Date
December 4, 2024
Initiation Date
October 1, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Pending

Product Description

Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN

Reason for Recall

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYLVANIA, SOUTH CAROLINA, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON and WISCONSIN. The country of Australia.

Code Information

Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending

Other recalls by Abbott Medical

  • Z-2405-2026 Class II — Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 33 (May 12, 2026)
  • Z-0458-2026 Class II — Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 (October 6, 2025)
  • Z-0459-2026 Class II — Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 (October 6, 2025)
  • Z-1557-2025 Class II — Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 0 (February 15, 2025)
  • Z-0753-2025 Class II — The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 365 (November 21, 2024)
  • Z-0491-2025 Class II — Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 m (October 17, 2024)
  • Z-0492-2025 Class II — Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile (October 17, 2024)
  • Z-0493-2025 Class II — Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO- (October 17, 2024)
  • Z-0494-2025 Class II — Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO (October 17, 2024)
  • Z-0495-2025 Class II — Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile (October 17, 2024)

FDA data resources