Home / Recalls / Abbott Medical / Z-1557-2025

Z-1557-2025 Class II Ongoing

Recalled by Abbott Medical — Sylmar, CA

FDA device recall Z-1557-2025 was initiated by Abbott Medical on February 15, 2025 and is designated Class II. Reason for recall: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. The recall status is ongoing. Affected quantity: 6 devices.

Recall Details

Product Type
Devices
Report Date
April 23, 2025
Initiation Date
February 15, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 devices

Product Description

Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.

Reason for Recall

Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and the country of Spain. There were five (5) LSP202V devices distributed within the United States (3 in FL, 1 in SC, 1 in WV) that are impacted by this issue, two (2) of which were implanted, see Attachment A.3 for list of serial numbers. There is 1 LSP112V device that is impacted by this issue, but this was distributed outside of the United States. See Attachment A.4 for list of OUS serial numbers.

Code Information

Model Number: LSP202V UDI-DI code: 05415067040725 Serial Numbers: 1357831, 1357869, 1357885, 1357894, 1357895 Model Number: LSP112V UDI-DI code: 05415067034472 Serial Number: 1357956

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-0459-2026 Class II — Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 (October 6, 2025)
  • Z-0458-2026 Class II — Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 (October 6, 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-0495-2025 Class II — Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile (October 17, 2024)
  • Z-0492-2025 Class II — Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile (October 17, 2024)
  • Z-0494-2025 Class II — Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO (October 17, 2024)
  • Z-0493-2025 Class II — Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO- (October 17, 2024)
  • Z-0551-2025 Class III — Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is inte (October 1, 2024)

FDA data resources