Cardiac Device Programmer Software May Fail to Terminate Test
St. Jude Medical's Merlin 2 programmer software can fail to stop a clinical Decrement Test and restore pacing parameters during in-clinic testing, affecting 401 devices worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall without reported hospitalizations or injuries. The software anomaly presents a risk of improper device function under specific testing conditions, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
St. Jude Medical, Cardiac Rhythm Management Division, is recalling the Merlin 2 PCS MER3700 programmer with Model MER3400 software due to a software anomaly. The recall affects 401 devices that have been distributed worldwide, including throughout all U.S. states and numerous countries.
A software anomaly can occur under specific circumstances when performing a Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices. During this test, the programmer may continue to execute the test instead of terminating it and restoring the permanent programmed pacing parameters. This may affect normal device operation.
Patients with affected devices should consult with their healthcare providers about this recall. St. Jude Medical can be contacted for additional information regarding the affected serial numbers and software versions.
The recalled product
- Product
- Merlin 2 PCS MER3700 programmer Model MER3400 software
- Manufacturer
- St. Jude Medical, Cardiac Rhythm Management Division
- Hazard
- software-anomaly
- device-malfunction
- pacing-parameter-failure
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModeratePower-Trialysis Slim-Cath Dialysis Catheters Recalled by Bard Access Systems
FDA (Devices) · 2026-07-08
- HighRayCare 2024A SP4 Oncology System Beam Set Delivery Note Data Loss
FDA (Devices) · 2026-07-08
- HighRayCare 2024A SP1 Oncology Information System Software Recall
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits Recalled Due to Lidocaine Quality Issues
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters Nationwide
FDA (Devices) · 2026-07-08