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St. Jude Medical recall records

13 reported ongoing

13 records in this archive. Latest source date Feb 3, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network ...

Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.

Class IIReported ongoing

Distribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, N...

Official source
FDA device enforcement

Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System pro...

Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.

Class IIReported ongoing

Distribution: U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A

Official source
FDA device enforcement

CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application ...

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

Class IIReported ongoing

Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NV, N...

Official source
FDA device enforcement

CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application...

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

Class IIReported ongoing

Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NV, N...

Official source
FDA device enforcement

CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.

Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, KUWAIT, NET...

Official source
FDA device enforcement

CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and ...

Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interf...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland,...

Official source
FDA device enforcement

CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and ...

Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interf...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland,...

Official source
FDA device enforcement

CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and ...

Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interf...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland,...

Official source
FDA device enforcement

CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and...

Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interf...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland,...

Official source
FDA device enforcement

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and man...

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 pote...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland,...

Official source
FDA device enforcement

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and man...

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 pote...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland,...

Official source
FDA device enforcement

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and man...

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 pote...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ireland,...

Official source

Reasons in these listed records

  • Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
  • Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
  • As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
  • One lot of product has dilators that are too short and will not extend outside the introducer sheath.

These examples come from this result page and are not a ranking of every recall reason.

Checking St. Jude Medical

Is there a recall on st. jude medical right now?

This archive contains 13 records, including 13 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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