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.
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 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
- Hazard
- inaccurate-battery-estimate
- software-defect
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 53 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VI
- VT
- WA
- WI
- WV
- WY
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