Reported Aug 10, 2022 · Ongoing
Merlin PCS 3650 programmer Model 3330 software
St. Jude Medical, Cardiac Rhythm Management Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical, Cardiac Rhythm Management Division · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- Merlin PCS 3650 programmer Model 3330 software
- Lot codes and dates
Software Model 3330 v26.0.1 rev 1 or earlierUDI/DI 05414734509725
- Amount recalled
- 29,996 programs
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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