The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1496-2022·Announced 2022-08-10

Merlin 2 PCS MER3400 programmer software recalled by St. Jude Medical

St. Jude Medical recalled Merlin 2 PCS MER3400 programmer software version 1.1.2 revision 1 or earlier in an FDA Class II recall. The recall affects 622 units distributed across the United States and internationally.

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: FDA Class II medical device recall affecting programming systems for implantable cardiac devices. No illnesses or deaths reported in the source material. Classified as High because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

St. Jude Medical, Cardiac Rhythm Management Division, is recalling Merlin 2 PCS MER3400 programmer software. This is an FDA Class II medical device recall.

The recall affects approximately 622 programmer units with software model MER3400 version 1.1.2 revision 1 or earlier (UDI/DI 05415067037121). These portable programming systems are used to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up procedures. The recalled units were distributed across the United States and internationally to numerous countries.

Patients and healthcare providers using affected programmers should contact St. Jude Medical for guidance on addressing this recall. The FDA Class II classification indicates a defect that has a reasonable probability of causing serious adverse health consequences.

The recalled product

Product
Merlin 2 PCS MER37000 programmer Model MER3400 software
Manufacturer
St. Jude Medical, Cardiac Rhythm Management Division
Category
Medical Device — Device Programming Software
Hazard
Affected units
622

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Software Model MER3400 v1.1.2 rev 1 or earlier.
  • UDI/DI 05415067037121

Distribution

Distributed in 54 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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