FDA recall, , Moderate risk
Merlin Patient Care System (PCS)
Software malfunction may occur during pacing capture threshold test.
Summary by Recall Canary from the FDA notice
What happened
Abbott Medical of Sylmar, California, began a recall of Merlin Patient Care System (PCS) software, specifically the Merlin PCS 3650 programmer Model 3330 software, on May 12, 2026. The FDA added the recall to its Enforcement Report and classified it on June 11, 2026. The reason stated by the agency is that a software malfunction may occur during a pacing capture threshold test of a pacemaker, resulting in the programmer not successfully communicating the command to terminate the test.
The recall involves 11182 programs and has nationwide distribution in the United States. The FDA's weekly enforcement report included this recall on June 17, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
- UDI-DI
- 05414734509725
Recall details
- Company began the recall
- Sold in
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
- Company
- Abbott MedicalSylmar, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98963
- Recall number
- Z-2405-2026
- Quantity recalled
- 11182 programs
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated