FDAFebruary 28, 2020device
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
What to do
FDA enforcement status: Terminated
Brands named
abbott
UPCs
0541473450066105414734509725
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software2026-05-12
- FDAi-STAT EG7+ cartridge; List Number: 03P76-25;2026-04-01
- FDAi-STAT G3+ cartridge; List Number: 03P78-26;2026-04-01
- FDAi-STAT EG6+ cartridge; List Number: 03P77-25;2026-04-01
- FDAProduct Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable2026-02-09
- FDAFreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.2025-11-24
- FDAFreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.2025-11-24
- FDAFreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.2025-11-24
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