St. Jude Medical 2023-03-15 Health serious FDA
Health · FDA · Recall #FDA-Z-1225-2023
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS… Recall
Issued March 15, 2023 · St. Jude Medical
In March 2023, St. Jude Medical recalled the CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
What you should do
- 1 Stop using CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact St. Jude Medical to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- St. Jude Medical
- Category
- Health
- Recall date
- March 15, 2023
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmar
- Recall number
- FDA-Z-1225-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- St. Jude Medical has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.