The Recall Desk
HighFDA (Devices)·Z-0964-2022·Announced 2022-04-27

Merlin PCS 3650 Programmer May Fail to Terminate Pacing Test Properly

A software anomaly in the Merlin PCS 3650 programmer may cause an in-clinic pacing test to fail terminating and prevent restoration of the implanted device's normal settings. Approximately 30,069 affected devices have been distributed 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 recall for an implantable cardiac device programmer with a software anomaly that could cause failure to restore proper pacing parameters. The hazard is risk-of-harm in a high-risk medical device with no reported illnesses or injuries, placing it in the Score 3 category per the rubric.

Plain-English summary

St. Jude Medical is recalling the Merlin PCS 3650 programmer Model 3330 software due to a software anomaly affecting implanted cardiac devices. Approximately 30,069 devices with the affected software version (v25.X.X) have been distributed worldwide across the United States and numerous international locations including Canada, Europe, Asia, and Australia.

The software contains an anomaly that may occur under very specific circumstances when healthcare providers execute a pacing capture Decrement Test in-clinic on implanted cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) devices. When this occurs, the programmer may continue executing the test instead of properly terminating it and restoring the patient's permanent programmed pacing parameters.

This anomaly affects patients with implanted ICD or CRT-D devices managed by the Merlin PCS 3650 programmer. Patients should contact their healthcare provider to determine if their device is affected by this recall.

The recalled product

Product
Merlin PCS 3650 programmer Model 3330 software
Manufacturer
St. Jude Medical, Cardiac Rhythm Management Division
Category
Medical Device — Implantable Cardiac Device Programmer
Hazard
Affected units
30,069

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 2 recalled by St. Jude Medical, Cardiac Rhythm Management Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · St. Jude Medical, Cardiac Rhythm Management Division

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Same hazard · software malfunction

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