Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer recall — FDA event 98963

What happened

Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

Who may be affected

• People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
• A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What to do

Affected products and models

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, VA, VT, WA, WI, WV, WY. OUS: Not provided yet

Units affected

See official FDA record

Category

Pacemakers

Timeline

1. May 12, 2026

   Recall initiated

   Date recorded by the FDA.

2. Jun 11, 2026

   Posted by FDA

   The recall event appeared in the FDA source.

3. Oct 8, 2026

   Last checked

   MedWatcher last reconciled this record with the openFDA export.