FDA Device recall Z-0988-2025
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Networ…
- FDA Device
- Class II
- ongoing
- Published 2025-01-29
On 2025-01-29 the FDA classified a Class II recall of CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Networ… by St Jude Medical, citing as a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0988-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-05 |
| Published | 2025-01-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000
Reason
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Identifiers
| code_info | MN6000 (Which interfaces with CM1100 for PES) UDI-DI Code: 05414734510035 Merlin ID / PES Serial Number: 027556711 CM11…MN6000 (Which interfaces with CM1100 for PES) UDI-DI Code: 05414734510035 Merlin ID / PES Serial Number: 027556711 CM1100 P180912371 444058655 CM1100 P240100658 494955560 CM1100 P230300384 497887091 CM1100 P180208671 513914390 CM1100 P230800825 742148364 CM1100 P220800695 751954397 CM1100 P211200289 000697912 CM1100 P181013064 001545862 CM1100 P220400808,P220100189 003473584 CM1100 P211100353 005842000 CM1100 P230100314 006333918 CM1100 P220600729 008418758 CM1100 P240300492 010473700 CM1100 P210700575 010485845 CM1100 P220100057 011307774 CM1100 P190800198 013397427 CM1100 P220500363 018103333 CM1100 P210201417 018852830 CM1100 P190900022 019716455 CM1100 P221100752 020956348 CM1100 P230500703 021148283 CM1100 P160900736 021410246 CM1100 P230800171 023874951 CM1100 P230400238 024386088 CM1100 P200100300 026473926 CM1100 P240500531 031880776 CM1100 P240300135 032455370 CM1100 P240300138 034701771 CM1100 P230300580 037825221 CM1100 P240100040 039458344 CM1100 P190700191 042069666 CM1100 |
|---|
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-0988-2025%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.