Reported Apr 2, 2025 · Ongoing
CardioMEMS Heart Failure (HF) System that consist of
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 Heart Failure (HF) System that consist of
3 of 3 products
| Model / number | Product as published |
|---|---|
CM3100 | CardioMEMS Backend Web Application |
CM4000 | Merlin.net Patient Care Network (PCN) Heart Failure Web Application |
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. |
- Lot codes and dates
- UDI-DI code05414734510035 CardioMEMS Heart
- Failure (HF) System that consist of-CardioMEMS Hospital System Model
- CM3100 Population 1 Serial NumbersM220300120 M220700122 M221100043 M221100062¿ M230300014 M231100047 M240100001¿ M240100040 In addition, 4 CM3100 have no serial number and are
- located at Treating Clinic Population 2Serial
- NumbersIn addition, seven device with no serial number - located at Treating
M220300029M220300031M220300041M220300069M220300079M220300113M220300162M220700130M220700131M220700140M220900031M220900038M220900109M221000019M221100013M230200053M230500034M230900025M231100031M231100057M240100066M240100074M240500083
- or Consulting Clinic Population 3Serial
- Numbers-CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000
162 of 162 codes
M220200009M220200013M220200022M220200045M220300001M220300003M220300005M220300007M220300010M220300016M220300019M220300034M220300036M220300045M220300047M220300048M220300061M220300076M220300078M220300081M220300085M220300089M220300090M220300093M220300098M220300110M220300112M220300118M220300128M220300129M220300133M220300152M220300155M220300157M220300160M220300161M220300166M220700030M220700032M220700043M220700044M220700051M220700057M220700062M220700065M220700078M220700084M220700091M220700101M220700106M220700119M220700121M220700134M220700138M220700141M220900021M220900028M220900032M220900040M220900041
- Amount recalled
- 193 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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