FDA Medical devices recall · January 1, 2025

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model… recall

Read the official FDA notice ↗

Product

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Programmer Model Number: 3650 UDI-DI code: 05414734509725 Software Version Number / Serial Numbers: 28.0.1 REV 2 12995 28.0.1 REV 2 16103 28.0.1 REV 2 30831 28.0.1 REV 2 12040778 28.0.1 REV 2 12041825 28.0.1 REV 2 12048943 28.0.1 REV 2 12050154 28.0.1 REV 2 12051352 28.0.1 REV 2 12051615 28.0.1 REV 2 12056133 28.0.1 REV 2 12713 28.0.1 REV 2 14655 28.0.1 REV 2 23324 28.0.1 REV 2 24050 28.0.1 REV 2 12042174 28.0.1 REV 2 12042239 28.0.1 REV 2 12048730 28.0.1 REV 2 11959 28.0.1 REV 2 16116 28.0.1 REV 2 16571 28.0.1 REV 2 27499 28.0.1 REV 2 12056125 28.0.1 REV 2 15378 28.0.1 REV 2 18041 28.0.1 REV 2 27164 28.0.1 REV 2 12045425 28.0.1 REV 2 12045483 28.0.1 REV 2 12870 28.0.1 REV 2 14910 28.0.1 REV 2 18143 28.0.1 REV 2 21904 28.0.1 REV 2 23317 28.0.1 REV 2 12043799 28.0.1 REV 2 12044806 28.0.1 REV 2 12055973 28.0.1 REV 2 24842 28.0.1 REV 2 12040739 28.0.1 REV 2 12042686 28.0.1 REV 2 12044212 28.0.1 REV 2 12045527 28.0.1 REV 2 12052141 28.0.1 REV 2 12055384 28.0.1 REV 2 12052537 28.0.1 REV 2 19660 28.0.1 REV 2 21099 28.0.1 REV 2 24610 28.0.1 REV 2 30022 28.0.1 REV 2 12044540 28.0.1 REV 2 12047076 28.0.1 REV 2 12053304 28.0.1 REV 2 12706 28.0.1 REV 2 20207 28.0.1 REV 2 20933 28.0.1 REV 2 22212 28.0.1 REV 2 25022 28.0.1 REV 2 27371 28.0.1 REV 2 12044759 28.0.1 REV 2 12045223 28.0.1 REV 2 12052322 28.0.1 REV 2 12056132 28.0.1 REV 2 12060627 28.0.1 REV 2 12061640 28.0.1 REV 2 11628 28.0.1 REV 2 11891 28.0.1 REV 2 20861 28.0.1 REV 2 22163 28.0.1 REV 2 25164 28.0.1 REV 2 25942 28.0.1 REV 2

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, WI, and WV. The countries of Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

States: Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina Tennessee Texas Utah Virginia Washington Wisconsin West Virginia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0753-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.