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U.S. Department of Health and Human Services

Class 2 Device Recall Merlin" Patient Care System (PCS) software

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 Class 2 Device Recall Merlin" Patient Care System (PCS) softwaresee related information
Date Initiated by FirmMay 12, 2026
Date PostedJune 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2405-2026
Recall Event ID 98963
PMA NumberP150035 
Product Classification Leadless pacemaker - Product Code PNJ
ProductMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Code Information Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
FEI Number 2017865
Recalling Firm/
Manufacturer		 Abbott Medical
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information ContactAlicia Swanson
1-408-8453427
Manufacturer Reason
for Recall		Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
FDA Determined
Cause 2		Software Design Change
ActionOn May 12 Abbott issued a Urgent Medical Device Recall notification via sales representative. Abbott ask consignees to take the following actions: Abbott has developed updated Merlin PCS 3650 programmer software (v28.9.1 rev 1 or higher) that resolves this behavior. Beginning with this notification, your Abbott Representative will upgrade programmer software to this software version . Abbott's service representative will proved a attestation to acknowledge receipt of the notification and software update. Please share this notification with others in your organization, as appropriate.
Quantity in Commerce11182 programs
DistributionUS 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = PNJ
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