Reported Jun 17, 2026 · Ongoing
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Abbott Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Medical · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
- Lot codes and dates
- Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
- Amount recalled
- 11182 programs
Where it was sold
Why it was recalled
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
This product could cause temporary or reversible health problems — stop using it.
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