Reported Sep 23, 2015 · Terminated
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable…
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@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
- Lot codes and dates
- ModelEX1150 Serial #:
3,258 of 3,258 codes
029020360510322812200027122000471220006312200065122000711220009312200100122001111220012012200122122001571220016512200168122001741220018712200235122002451220025012200331122003331220035112200367122003691220037112200399122004321220044912200459122004661220047112200478122005221220053912200574122005821220062112200641122006581220066112200679122006801220070012200738122007491220075412200758122007711220077212200788122007911220080012200832122008451220085012200851122008641220086812200877
- ModelEX1150 Serial #:
- Amount recalled
- 259,214 transmitters (U.S. distribution) 23,604 (foreign distribution)
Where it was sold
- Nationwide
Why it was recalled
Some devices exhibit backup VVI operation due to a backup reset.
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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