Abbott Medical Merlin PCS 3650 Programmer Model 3330 Software Anomaly Risk
Abbott Medical recalls Merlin PCS 3650 programmer model 3330 due to software anomaly that may cause leadless pacemaker programming failure with temporary loss of telemetry. Affected units have specific software versions and serial numbers listed in the recall notice.
Lower-risk recall
Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.
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What happened, in plain English
Abbott Medical is recalling its Merlin PCS 3650 programmer model 3330 because a software issue can cause programming failures during leadless pacemaker finalization, resulting in temporary loss of telemetry and no pacing. This could lead to improper device function if not corrected. Read more at govinfonow.com/recall/53443-abbott-medical-merlin-pcs-3650-programmer-model-3330-software-anomaly.
Source Summary by GovInfoNow · govinfonow.com/recall/53443-abbott-medical-merlin-pcs-3650-programmer-model-3330-software-anomaly · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0753-2025
Cite this page
“Abbott Medical Merlin PCS 3650 Programmer Model 3330 Software Anomaly Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53443-abbott-medical-merlin-pcs-3650-programmer-model-3330-software-anomaly. Based on FDA recall #Z-0753-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0753-2025%22&limit=1).
Why it’s dangerous
During finalization of leadless pacemaker programming, a specific sequence of actions combined with a brief loss of telemetry (<2 seconds) can cause the programming step to fail. If this occurs, the device displays a 'loss of telemetry detected' message and stops pacing, potentially leading to improper device function.
Who’s affected
Users of the Merlin PCS 3650 programmer model 3330 with specific software versions (28.0.1 REV 2) and serial numbers listed in the recall notice are affected. Medical professionals who program leadless pacemakers with this device are most at risk.
How to tell if you have this one
Check if your Merlin PCS 3650 programmer has software version 28.0.1 REV 2 and one of the serial numbers listed in the recall notice (many are provided in the record). The device is used for programming Abbott Medical implantable devices.
- Brand
Abbott Medical- Category
Medical device
What to do — step by step
Check Device Details
Verify your Merlin PCS 3650 programmer has software version 28.0.1 REV 2 and one of the serial numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 43 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN TX, UT, VA, WA,…” 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, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0753-2025 (November 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0753-2025 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.