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Lower risk Medical device recall · FDA · Published February 15, 2025

Abbott Aveir DR Leadless Pacemaker Recall: Risk of Premature Battery Failure

Abbott Medical recalls Aveir DR leadless pacemakers with specific UDI-DI codes due to potential premature battery failure from higher than normal temperatures during manufacturing.

🇺🇸 FDA recall #Z-1557-2025Medical deviceAbbott Medical ›
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Recalling firmAbbott Medical15900 Valley View Ct · Sylmar, CA 91342-3577
✎ GovInfoNow plain-language explainer

Abbott Medical is recalling certain Aveir DR leadless pacemakers that may have been exposed to higher temperatures during manufacturing, which could cause premature battery failure. This recall affects patients with these specific models and serial numbers. Read more at govinfonow.com/recall/52855-abbott-aveir-dr-leadless-pacemaker-recall-risk-of-premature-battery.

Source Summary by GovInfoNow · govinfonow.com/recall/52855-abbott-aveir-dr-leadless-pacemaker-recall-risk-of-premature-battery · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1557-2025

Cite this page

“Abbott Aveir DR Leadless Pacemaker Recall: Risk of Premature Battery Failure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52855-abbott-aveir-dr-leadless-pacemaker-recall-risk-of-premature-battery. Based on FDA recall #Z-1557-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1557-2025%22&limit=1).

The FDA announced on Feb. 15, 2025, that Abbott Medical is recalling six Aveir DR Leadless Pacemaker devices due to a manufacturing issue that may cause premature battery failure. Owners should contact the manufacturer for remedy details.

How to tell if you have it

  • Brand: Abbott Medical
  • Product: Aveir DR Leadless Pacemaker (LP) Ventricular Device
  • Model Number: LSP202V, UDI-DI code: 05415067040725, Serial Numbers: 1357831, 1357869, 1357885, 1357894, 1357895
  • Model Number: LSP112V, UDI-DI code: 05415067034472, Serial Number: 1357956

The hazard

According to the FDA, leadless pacemakers may have been exposed to higher than normal temperatures during manufacturing, which may result in premature battery failure. The recall involves six devices distributed worldwide, with five impacting the U.S. (three in FL, one in SC, one in WV) and one outside the U.S.

Context

GovInfoNow's records show Abbott Medical has 15 other recalls on record since Oct. 14, 2019. Other recent recalls of similar products include Abbott Medical Merlin PCS 365: Software malfunction risks pacemaker test failure (May 12, 2026), Abbott Medical - Medical Devices and Equipment (Oct. 6, 2025), and Abbott Medical Merlin PCS 3650 Programmer Model 3330 Software Anomaly Risk (Nov. 21, 2024). Other recent recalls of similar products include Philips Allura Xper FD10C Medical System Recall: Risk of Electrical Short-Circuits (Dec. 15, 2025), HeartMate 11V Backup Battery Recall: Battery Failures Risk (May 13, 2026), and Philips Allura Xper FD10F Medical System Recall: Risk of Electrical Short-Circuits (Dec. 15, 2025).

How to tell if you have this one

Check for the model numbers LSP202V (UDI-DI code 05415067040725) or LSP112V (UDI-DI code 05415067034472) on the device. The affected units have specific serial numbers listed in the recall notice.

  • Brand
    Abbott Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Identify the model number and UDI-DI code on your device to confirm if it is in the recall list.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 3 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, South Carolina, West Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Feb 15, 202512. FDA classified it Class II: Apr 14, 202523. Published in FDA’s Enforcement Report: Apr 23, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using my pacemaker immediately?

No, the recall does not require immediate discontinuation. The device can continue to function but may have a risk of premature battery failure.

What should I do if my pacemaker is in the recall list?

Contact Abbott Medical directly to confirm your device's status and follow their instructions for potential replacement or repair.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1557-2025 (February 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1557-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA