Z-1557-2025Class II

Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V...

Name: Z-1557-2025 Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V...
Creator: Abbott Medical
Published: 2025-02-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-02-15 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Medical began a recall of Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless... on 2025-02-15. FDA classified it as Class II and gives the reason as "Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1557-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-15
Posted: 2025-04-14
Recalling firm: Abbott Medical
Product: 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.
Product code: PNJ Leadless Pacemaker
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 02/15/2025, the firm communicated with the implanting/following physicians via phone call and in-person meeting. Customers were informed that a subset of Aveir Leadless pacemaker devices manufactured in January 2025 had experienced a departure from manufacturing baseline parameters due to incorrect equipment set-up. As a result of this issue, the glass insulator separating the battery from the electronics may have microcracks that could lead to the reduction in longevity of the device and loss of functionality. Customers are instructed to: Recognizing that each patient requires individual consideration, Abbott recommends: "Consideration of device retrieval and/or replacement (with a leadless or transvenous device), particularly if your patient is pacemaker dependent. "Follow-up actions should consider evaluation of individual patient needs, disease states, and co-morbidities. "Timing of device replacement should depend on the patient s clinical characteristics. Customer were also instructed to acknowledge the customer notification by returning Acknowledgement Form to [email protected] Additional notification of customers were on 02/15/2025 and 02/27/2025 via email.
Quantity in commerce: 6 devices
Distribution: 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.
Product codes and lots: Model Number: LSP202V UDI-DI code: 05415067040725 Serial Numbers: 1357831, 1357869, 1357885, 1357894, 1357895 Model Number: LSP112V UDI-DI code: 05415067034472 Serial Number: 1357956

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1557-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1557-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-14

Product code PNJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)