FDA Device recall Z-1427-2025
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM…
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM… by St Jude Medical, citing 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 informatio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1427-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-03 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | UDI-DI code: 05414734510035 CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3…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 M2203000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1427-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.