Reported Jan 29, 2025 · Ongoing
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000…
St. Jude Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical · 387 Technology Cir Nw Ste 500 · Atlanta, GA · 30313-2424
Is this the product you have?
- CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 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
- Lot codes and dates
- MN6000 (Which interfaces
- with CM3000 for HES) UDI-DI Code05414734510035
- HES Serial Number/Clinic Merlin ID
86 of 86 codes
M14040047050011924M14090116250012084M15010223850013199M15030265550011863M150905419100351M16110792950012353M16120797650012166M17010809450011331M17020815950012146M170208161100268M17040824450015053M17050827550000752M17110842650051809M17110843750011840M17110844250011887M18020850950011887M180308526100710M18060865150011332M18060865250025010M18060865350015252M18060866950015252M18060871250060412M18060872750017544M18100888250038595M19020899050040301M19020899450040237M19030001050011866M190400008500150M190700005100605M200400018100359
- Amount recalled
- 431 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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