CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI code: 05414734510035 CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 Population 1 Serial Numbers: M220300120 M220700122 M221100043 M221100062¿ M230300014 M231100047 M240100001¿ M240100040 In addition, 4 CM3100 have no serial number and are located at Treating Clinic Population 2: Serial Numbers: M220300029 M220300031 M220300041 M220300069 M220300079 M220300113 M220300162 M220700130 M220700131 M220700140 M220900031 M220900038 M220900109 M221000019 M221100013 M230200053 M230500034 M230900025 M231100031 M231100057 M240100066 M240100074 M240500083 In addition, seven device with no serial number - located at Treating or Consulting Clinic Population 3: Serial Numbers: M220200009 M220200013 M220200022 M220200045 M220300001 M220300003 M220300005 M220300007 M220300010 M220300016 M220300019 M220300034 M220300036 M220300045 M220300047 M220300048 M220300061 M220300076 M220300078 M220300081 M220300085 M220300089 M220300090 M220300093 M220300098 M220300110 M220300112 M220300118 M220300128 M220300129 M220300133 M220300152 M220300155 M220300157 M220300160 M220300161 M220300166 M220700030 M220700032 M220700043 M220700044 M220700051 M220700057 M220700062 M220700065 M220700078 M220700084 M220700091 M220700101 M220700106 M220700119 M220700121 M220700134 M220700138 M220700141 M220900021 M220900028 M220900032 M220900040 M220900041 M220900044 M220900074 M220900078 M220900082 M220900087 M220900093 M220900096 M220900103 M220900113 M220900122 M220900123 M221000014 M221000015 M221000022 M221000029 M221000045 M221100010 M221100016 M221100026 M221100045 M221100048 M221100057 M221100066 M230100006 M230100017 M230200020 M230200034 M230200036 M230200041 M230200046 M230200066 M230200072 M230200073 M230300004 M230300010 M230300012 M230300013 M230300025 M230300034 M230300043 M230400005 M230400012 M230400018 M230400019 M230400021 M230400022 M230400023 M230400025 M230400029 M230400031 M230400032 M230400039 M230400041 M230400043 M230400050 M230500007 M230500015 M230500024 M230900011 M230900013 M230900014 M230900015 M230900017 M230900030 M230900034 M231100026 M231100027 M231100030 M231100032 M231100046 M231100051 M231100056 M231100061 M231100071 M231100073 M231200001 M240100004 M240100011 M240100012 M240100015 M240100028 M240100032 M240100035 M240100037 M240100043 M240100063 M240100067 M240100070 M240100073 M240100088 M240500051 M240500056 M240500059 M240500061 M240500073 M240500076 M240500079 M240500086 M240500095 M240500096 M240500098 M240500100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- St. Jude Medical
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
Product Codes/Lot Numbers:
UDI-DI code: 05414734510035 CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 Population 1 Serial Numbers: M220300120 M220700122 M221100043 M221100062¿ M230300014 M231100047 M240100001¿ M240100040 In addition, 4 CM3100 have no serial number and are located at Treating Clinic Population 2: Serial Numbers: M220300029 M220300031 M220300041 M220300069 M220300079 M220300113 M220300162 M220700130 M220700131 M220700140 M220900031 M220900038 M220900109 M221000019 M221100013 M230200053 M230500034 M230900025 M231100031 M231100057 M240100066 M240100074 M240500083 In addition, seven device with no serial number - located at Treating or Consulting Clinic Population 3: Serial Numbers: M220200009 M220200013 M220200022 M220200045 M220300001 M220300003 M220300005 M220300007 M220300010 M220300016 M220300019 M220300034 M220300036 M220300045 M220300047 M220300048 M220300061 M220300076 M220300078 M220300081 M220300085 M220300089 M220300090 M220300093 M220300098 M220300110 M220300112 M220300118 M220300128 M220300129 M220300133 M220300152 M220300155 M220300157 M220300160 M220300161 M220300166 M220700030 M220700032 M220700043 M220700044 M220700051 M220700057 M220700062 M220700065 M220700078 M220700084 M220700091 M220700101 M220700106 M220700119 M220700121 M220700134 M220700138 M220700141 M220900021 M220900028 M220900032 M220900040 M220900041 M220900044 M220900074 M220900078 M220900082 M220900087 M220900093 M220900096 M220900103 M220900113 M220900122 M220900123 M221000014 M221000015 M221000022 M221000029 M221000045 M221100010 M221100016 M221100026 M221100045 M221100048 M221100057 M221100066 M230100006 M230100017 M230200020 M230200034 M230200036 M230200041 M230200046 M230200066 M230200072 M230200073 M230300004 M230300010 M230300012 M230300013 M230300025 M230300034 M230300043 M230400005 M230400012 M230400018 M230400019 M230400021 M230400022 M230400023 M230400025 M230400029 M230400031 M230400032 M230400039 M230400041 M230400043 M230400050 M230500007 M230500015 M230500024 M230900011 M230900013 M230900014 M230900015 M230900017 M230900030 M230900034 M231100026 M231100027 M231100030 M231100032 M231100046 M231100051 M231100056 M231100061 M231100071 M231100073 M231200001 M240100004 M240100011 M240100012 M240100015 M240100028 M240100032 M240100035 M240100037 M240100043 M240100063 M240100067 M240100070 M240100073 M240100088 M240500051 M240500056 M240500059 M240500061 M240500073 M240500076 M240500079 M240500086 M240500095 M240500096 M240500098 M240500100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1427-2025
Related Recalls
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.
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.