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Lower risk Medical device recall · FDA · Published May 16, 2024

Abbott Proclaim XR 5 Pulse Generator Recall: Shorter Replacement Warning

Abbott recalls Proclaim XR 5 implantable pulse generators with shorter-than-labeled replacement warning. Affected units may need earlier replacement to prevent complications.

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

🇺🇸 FDA recall #Z-2358-2024Medical deviceAbbott Medical ›
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Contact the company

Recalling firmAbbott Medical6901 Preston Rd · Plano, TX 75024-2508
✎ GovInfoNow plain-language explainer

Abbott is recalling Proclaim XR 5 implantable pulse generators that may require earlier replacement than labeled. This could lead to complications if the device fails before the intended replacement time. Read more at govinfonow.com/recall/55053-abbott-proclaim-xr-5-pulse-generator-recall-shorter-replacement-warning.

Source Summary by GovInfoNow · govinfonow.com/recall/55053-abbott-proclaim-xr-5-pulse-generator-recall-shorter-replacement-warning · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2358-2024

Cite this page

“Abbott Proclaim XR 5 Pulse Generator Recall: Shorter Replacement Warning.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55053-abbott-proclaim-xr-5-pulse-generator-recall-shorter-replacement-warning. Based on FDA recall #Z-2358-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2358-2024%22&limit=1).

The FDA announced on May 16, 2024, that Abbott Medical is recalling its Proclaim XR 5 Implantable Pulse Generator (REF 3660) because the time between the device reaching its elective replacement indicator and end of service may be shorter than labeled. The recall affects 83,511 units distributed worldwide.

How to tell if you have it

  • Brand: Abbott Medical
  • Product: Proclaim XR 5 Implantable Pulse Generator
  • REF: 3660
  • Description: Sterile EO, Rx Only
  • UDI: 05415067031419
  • Serial Numbers: All Serial Numbers
  • Quantity: 83,511 units

The hazard

According to the FDA, the hazard is that the duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

Context

GovInfoNow's records show Abbott Medical has 15 other recalls on record since October 14, 2019. Other recent recalls include the Abbott Medical Merlin PCS 365 (May 12, 2026), the Abbott Medical Liberta RC DBS IPG Model 62400 (October 6, 2025), and the Abbott Aveir DR Leadless Pacemaker (February 15, 2025). Other recent recalls of similar products include the Philips Allura Xper FD10C Medical System (December 15, 2025), the Boston Scientific LUX-Dx Cardiac Monitor System (August 6, 2026), and the Inspire Stimulation Lead (May 11, 2026).

How to tell if you have this one

Check the serial number on your device. Affected units have the UDI: 05415067031419 and all serial numbers listed in the recall.

  • Brand
    Abbott Medical
  • Category
    Medical device
FDA recall event · 12 products

All 12 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 ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, GUAM, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY, LOUISIANA,MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO, NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, PUERTO RICO, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VERMONT, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN, WYOMING and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy , Japan, Korea, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Reunion Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-2358-2024Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only; UDI: 05415067031419/ All Serial Numbers83,511 units
Z-2359-2024Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only; UDI:05415067020208/ All Serial Numbers1379 units
Z-2360-2024Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only; UDI:05415067031426/ All Serial Numbers9,006 units
Z-2361-2024Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only; 05415067020239/ All Serial Numbers569 units
Z-2362-2024Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only; 05415067023247/ All Serial Numbers1,119
Z-2363-2024Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only; 05415067023254/ All Serial Numbers457 unity
Z-2364-2024Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only; 05415067046383/ All Serial Numbers8,401 units
Z-2365-2024Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only; 05415067046390/ All Serial Numbers38 units
Z-2366-2024Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only; 05415067046406/ All Serial Numbers1086 units
Z-2367-2024Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only; 05415067020215/ All Serial Numbers21,843 units
Z-2368-2024Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only; 05415067020222/ All Serial Numbers30,673 units
Z-2369-2024Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only; 05415067020192/ All Serial Numbers38,530 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Look for the UDI: 054:15067031419 on your device's label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide - US Nationwide distribution including in the states of ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, GUAM, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

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

1. Firm started the recall: May 16, 202412. FDA classified it Class II: Jul 16, 202423. Published in FDA’s Enforcement Report: Jul 24, 202432024
  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

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to replace my device immediately?

The recall does not require immediate replacement. The device may need replacement earlier than labeled, but the exact timing depends on individual use.

What should I do if I have the affected device?

Check your device's serial number against the list provided in the recall. If it matches, contact Abbott Medical for further instructions.

Is this device safe to use?

The device is safe to use as long as it is functioning properly and the replacement indicator is not reached earlier than labeled.

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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-2358-2024 (May 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2358-2024 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.
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