Lower risk Medical device recall · FDA · Published February 28, 2020

St. Jude Medical Merlin PCS 3650 Software Upgrade Kit: Risk of Incorrect Energy Settings

St. Jude Medical recalls Merlin PCS 3650 Software Upgrade Kit (REF 3330) due to potential incorrect energy settings during device programming, which may not alert users to retained values.

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

🇺🇸 FDA recall #Z-1700-2020Medical device St. Jude Medical ›

Lower-risk recall

Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.

Take action

Contact the company

Recalling firmAbbott15900 Valley View Ct · Sylmar, CA 91342-3577

✎ GovInfoNow plain-language explainer

St. Jude Medical is recalling the Merlin PCS 3650 Software Upgrade Kit (REF 3330) because software anomalies could cause the device to use incorrect energy levels without alerting users. This may lead to improper device programming if non-applicable shock energy values are selected. Read more at govinfonow.com/recall/65729-st-jude-medical-merlin-pcs-3650-software-upgrade-kit-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65729-st-jude-medical-merlin-pcs-3650-software-upgrade-kit-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1700-2020

Cite this page

“St. Jude Medical Merlin PCS 3650 Software Upgrade Kit: Risk of Incorrect Energy Settings.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65729-st-jude-medical-merlin-pcs-3650-software-upgrade-kit-risk. Based on FDA recall #Z-1700-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1700-2020%22&limit=1).

Abbott recalled the Merlin PCS 3650 Software Upgrade Kit (REF 3330) on Feb. 28, 2020, because a software anomaly may cause the device to retain a previously programmed energy level without alerting the user, according to the FDA.

How to tell if you have it

Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical
UPC 05414734500661
UPC 05414734509725

The hazard

Internal testing identified software anomaly scenarios where selecting a non-applicable shock energy value causes the device to continue using the previously programmed energy level. The user will not be alerted that the selected value was not retained.

Context

GovInfoNow's records show Abbott has 12 other recalls on record since April 5, 2018. Other recent recalls of similar products include Abbott TactiFlex Sensor Catheter Recall (Sept. 10, 2025) and Abbott Amplatzer TorqVue LP Delivery System Recall (March 17, 2025). Medtronic issued a software issue recall for the Restore CP App Model A71100 on Nov. 20, 2025, and Fresenius Kabi recalled the Ivenix Infusion System on May 6, 2026.

How to tell if you have this one

Check for the Merlin PCS 3650 Software Upgrade Kit (REF 3330) with serial numbers listed in Attachment B.1 Programmers or devices listed in Attachment B.2 Devices. The software version is 24.6.1 for affected units.

Brand
St. Jude Medical
Product
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version is 24.6.1 for affected units by checking the device label.
Review Serial Numbers
Compare your programmer's serial number with the list in Attachment B.1 Programmers to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in 39 states and D.C..

FDA distribution: “U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no OUS consignees…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 4.1 years after the firm started it.

Feb 28, 2020Firm started the recall
Apr 10, 2020FDA classified it Class II
Apr 22, 2020Published in FDA’s Enforcement Report
Apr 18, 2024FDA terminated the recall

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/65729-st-jude-medical-merlin-pcs-3650-software-upgrade-kit-risk">St. Jude Medical Merlin PCS 3650 Software Upgrade Kit: Risk of Incorrect Energy Settings (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-1700-2020 (February 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1700-2020 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.