The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0965-2022·Announced 2022-04-27

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category
Medical Device — Cardiac Pacemaker Programmer
Hazard
Affected units
401

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 →

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