Reported Nov 15, 2023 · Ongoing
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary…
St. Jude Medical
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 · 387 Technology Cir Nw Ste 500 · Atlanta, GA · 30313-2424
Is this the product you have?
- CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
- Lot codes and dates
- Model Number CM1100
- UDI/DI05414734509800
- Serial Numbers
2,712 of 2,712 codes
P150800220P150800222P150800226P150800240P150800242P150800245P150800246P150800249P150800262P150800263P150800264P150800265P150800266P150800267P150800268P150800273P150800277P150900313P150900315P150900318P150900319P150900322P150900333P150900334P150900335P150900337P150900343P150900344P150900349P150900350P160100406P160100410P160100412P160100414P160100416P160100419P160100422P160200429P160200434P160200435P160200440P160200442P160200451P160200452P160200453P160200456P160200459P160200464P160200466P160200469P160200476P160200479P160200480P160200486P160200487P160200488P160200489P160200490P160200493P160200498
- Amount recalled
- 36,153 units
Where it was sold
- Nationwide
Why it was recalled
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
This product could cause temporary or reversible health problems — stop using it.
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