Lower riskMedical device recall · FDA · Published May 12, 2026
Abbott Medical Merlin PCS 365: Software malfunction risks pacemaker test failure
Abbott Medical recalls Merlin PCS 3650 programmer software versions 25.0.1-28.7.1 due to potential failure during pacemaker test. Affected units sold in US with GTIN 05414734509725.
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Take action
Contact the company
📍Recalling firmAbbott Medical15900 Valley View Ct · Sylmar, CA 91342-3577
“Abbott Medical Merlin PCS 365: Software malfunction risks pacemaker test failure.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49184-abbott-medical-merlin-pcs-365-software-malfunction-risks-pacemaker-test. Based on FDA recall #Z-2405-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2405-2026%22&limit=1).
The FDA announced on May 12, 2026, that Abbott Medical is voluntarily recalling Merlin Patient Care System software due to a malfunction that may prevent termination of pacing capture threshold tests. Owners should contact Abbott Medical for remedy details.
How to tell if you have it
Brand: Abbott Medical
Product: Merlin Patient Care System (PCS) software Merlin PCS 3650 programmer Model 3330 software
UPC: 05414734509725
Software Versions: 25.0.1 - 28.7.1
The hazard
According to the FDA, a software malfunction may occur during pacing capture threshold testing of a pacemaker, resulting in the programmer not successfully communicating the command to terminate the test.
Context
GovInfoNow's records show Abbott Medical has issued 15 other recalls since October 14, 2019. Recent brand recalls include the Liberta RC DBS IPG Model 62400 on October 6, 2025, and the Aveir DR Leadless Pacemaker on February 15, 2025. Other recent recalls of similar products include Boston Scientific CRT-P Pacemakers (March 19, 2026), Philips Cardiac Workstation 7000 (July 1, 2026), and Boston Scientific Pacemakers (March 19, 2026).
How to tell if you have this one
Check if your Merlin PCS 3650 programmer has software versions 25.0.1 through 28.7.1. Units sold in the US with GTIN 05414734509725 are affected.
Brand
Abbott Medical
Product
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your software version by checking the device's display or documentation.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,…” 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 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2405-2026 (May 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2405-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.