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Lower risk Medical device recall · FDA · Published February 2, 2023

Boston Scientific LATITUDE NXT Software Recall: HeartLogic Index Not Visible in Patient

Boston Scientific recalls LATITUDE NXT System Server Software Model 6460 due to HeartLogic Index and Yellow Alerts not being visible in patient management systems after 8 months of 2022. Affected patients may need to contact support for updates.

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

🇺🇸 FDA recall #Z-1216-2023Medical deviceBoston Scientific ›
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Contact the company

Recalling firmBoston Scientific Corporation4100 Hamline Ave N · Saint Paul, MN 55112-5700
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling LATITUDE NXT System Server Software Model 6460 because it stopped sending enablement requests to their support system for 8 months in 2022. This means healthcare providers might not see HeartLogic Index data or Yellow Alerts in patient management, which could affect care decisions. Read more at govinfonow.com/recall/58967-boston-scientific-latitude-nxt-software-recall-heartlogic-index-not-visible.

Source Summary by GovInfoNow · govinfonow.com/recall/58967-boston-scientific-latitude-nxt-software-recall-heartlogic-index-not-visible · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1216-2023

Cite this page

“Boston Scientific LATITUDE NXT Software Recall: HeartLogic Index Not Visible in Patient.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58967-boston-scientific-latitude-nxt-software-recall-heartlogic-index-not-visible. Based on FDA recall #Z-1216-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1216-2023%22&limit=1).

The FDA announced on Feb. 2, 2023, that Boston Scientific Corporation is voluntarily recalling its LATITUDE NXT Remote Patient Management System and LATITUDE NXT System Server Software Model 6460. The recall affects 1,531 patient data records due to a hazard where the system failed to send up enablement requests.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460
  • UDI-DI: 00802526613876

The hazard

Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls of similar products include Boston Scientific Imager II Angiographic Catheters Recall (Aug. 24, 2026), Boston Scientific LUX-Dx Cardiac Monitor System Recall (Aug. 6, 2026), and Boston Scientific StoneSmart Connect Console Power Adapters May Fail Safety Testing (July 22, 2026). Other recent recalls of similar products include GE HealthCare ApexPro v6.0 eDelivery Software Recall (April 24, 2026), GE HealthCare CARESCAPE Telemetry Server ARK-2250L Recall (April 24, 2026), and GE Medical Systems Portrait Compute V1.2 Software Recall (July 20, 2026).

How to tell if you have this one

Check for the LATITUDE NXT System Server Software Model 6460 with UDI-DI: 00802526613876. The software was sold in the U.S. between 2022 and 2023.

  • Brand
    Boston Scientific
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Support

    Reach out to Boston Scientific Customer Support for guidance on updating the software or resolving visibility issues.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 28 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution to the healthcare facilities and healthcare providers are located in CA, CO, DE, FL, GA, ID, IL, IN, IA, KY, ME, MD, MA, NV, NH, NJ, NY, NC, OH, PA, RI, SC, TN TX, VA, WA, WV, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Feb 2, 202312. FDA classified it Class II: Mar 3, 202323. Published in FDA’s Enforcement Report: Mar 15, 202332023
  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.

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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-1216-2023 (February 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1216-2023 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