The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1495-2022·Announced 2022-08-10

Pacemaker Programmer Software May Display Overestimated Battery Longevity

St. Jude Medical's Merlin PCS 3650 programmer software may display overestimated predicted battery longevity for certain pacemakers. This could affect clinical decision-making regarding device maintenance and replacement timing.

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 involving a potential software defect in a critical medical device. The hazard is a risk-of-harm product where injury has not yet been reported in the source material. Per the severity rubric, risk-of-harm products without reported injury receive a High (Score 3) rating.

Plain-English summary

St. Jude Medical's Merlin PCS 3650 programmer Model 3330 software is subject to a Class II FDA recall. The affected software versions are Model 3330 v26.0.1 rev 1 or earlier. Approximately 29,996 programs have been distributed in the United States and internationally.

The Merlin PCS 3650 programmer software and the Merlin.net remote monitoring software application may display overestimated predicted battery longevity for certain pacemakers. Clinicians and patients rely on this battery longevity information to manage pacemaker care and make decisions about device maintenance and replacement timing.

This potential defect in battery longevity display could result in inaccurate battery life predictions being used for clinical decision-making. The issue directly affects the ability to accurately determine when a pacemaker's battery will need replacement.

The recalled product

Product
Merlin PCS 3650 programmer Model 3330 software
Manufacturer
St. Jude Medical, Cardiac Rhythm Management Division
Category
Medical Device — Pacemaker Programmer
Hazard
Affected units
29,996

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 3330 v26.0.1 rev 1 or earlier
  • UDI/DI 05414734509725

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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