Lower risk Medical device recall · FDA · Published May 22, 2024

Abbott Infinity 7 Pulse Generator Recall: Risk of Therapy Loss

Abbott Medical recalls Infinity 7 implantable pulse generators with potential therapy loss due to incorrect end-of-service dates. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2432-2024Medical device Abbott Medical ›

Lower-risk recall

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

Take action

Contact the company

Recalling firmAbbott Medical6901 Preston Rd · Plano, TX 75024-2508

✎ GovInfoNow plain-language explainer

Abbott is recalling Infinity 7 implantable pulse generators that may stop working earlier than labeled, risking loss of therapy. This affects patients who need ongoing medical treatment from the device. Read more at govinfonow.com/recall/55027-abbott-infinity-7-pulse-generator-recall-risk-of-therapy-loss.

Source Summary by GovInfoNow · govinfonow.com/recall/55027-abbott-infinity-7-pulse-generator-recall-risk-of-therapy-loss · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2432-2024

Cite this page

“Abbott Infinity 7 Pulse Generator Recall: Risk of Therapy Loss.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55027-abbott-infinity-7-pulse-generator-recall-risk-of-therapy-loss. Based on FDA recall #Z-2432-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2432-2024%22&limit=1).

The FDA announced on May 22, 2024, that Abbott Medical is recalling its Infinity 7 Implantable Pulse Generator due to a potential for loss of therapy. The hazard stems from the device's replacement indicator and end-of-service date being shorter than indicated in the product labeling.

How to tell if you have it

Brand: Abbott Medical
Product: Infinity 7, Implantable Pulse Generator
REF: 6663
Sterility: SterileEO
Rx Status: Rx Only
Serial numbers/UDI: 05415067020277
Quantity: 1198 units

The hazard

According to the FDA, there is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling. This discrepancy could potentially result in loss of therapy.

Context

GovInfoNow's records show Abbott Medical has 15 other recalls on record since October 14, 2019. Other recent recalls of similar products include Abbott Medical Merlin PCS 365 (May 12, 2026), Abbott Medical Liberta RC DBS IPG Model 62400 (October 6, 2025), and Abbott Aveir DR Leadless Pacemaker (February 15, 2025). Other recent recalls of similar products include Philips IntelliVue MX40 (October 31, 2025), GE HealthCare Telemetry Server (April 24, 2026), and Boston Scientific LUX-Dx Cardiac Monitor System (August 6, 2026).

How to tell if you have this one

Check the serial number on your device. Affected units have the specific serial number 0541506: 020277.

Brand
Abbott Medical
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, WA, WI, WY and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-2429-2024	Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only; All Serial numbers/UDI:05415067030016/05415067020246	5,900 units
Z-2430-2024	Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only; All Serial numbers/UDI: 05415067020253	5,900 units
Z-2431-2024	Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only; All Serial numbers/UDI: 05415067030023 and 05415067020260	20,790 units
Z-2432-2024	Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only; All Serial numbers/UDI: 05415067020277	1198 units

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Look for the serial number on your Abbott Infinity 7 implantable pulse generator.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 34 states.

FDA distribution: “Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, WA, WI, WY and the countries of Algeria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming.

Recall timeline

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

May 22, 2024Firm started the recall
Jul 25, 2024FDA classified it Class II
Jul 31, 2024Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/55027-abbott-infinity-7-pulse-generator-recall-risk-of-therapy-loss">Abbott Infinity 7 Pulse Generator Recall: Risk of Therapy Loss (GovInfoNow)</a>

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-2432-2024 (May 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2432-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.