St. Jude Medical recalls CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model…
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…
Read the official notice →- Date
- 2025-04-02
- Country
- United States
- Brand
- St. Jude Medical
- Product
- CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model…
- Classification
- Class II
- Units
- U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More St. Jude Medical recalls
- 2025-01-29
USSt. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care…
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
FDA · DeviceSt. Jude MedicalWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →- US
St. Jude Medical recalls Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System…
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
FDA · DeviceSt. Jude MedicalU.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/AOfficial notice → - 2024-07-24
- US
St. Jude Medical recalls St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
- 2023-11-15
- US
St. Jude Medical recalls CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure…
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
FDA · DeviceSt. Jude MedicalWorldwide distribution - US Nationwide and the countries of ARGENTINA,…Official notice → - 2023-03-15
- US
St. Jude Medical recalls CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA)…
Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of…
FDA · DeviceSt. Jude MedicalWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
St. Jude Medical recalls CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA)…
Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits…
FDA · DeviceSt. Jude MedicalWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
Other drugs & medical recalls in the United States
- 2025-04-02
- US
Zimmer, Inc. recalls NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
FDA · DeviceZimmer, Inc.Worldwide - US Nationwide distribution in the states pf CA, KS, MA, MD, ME,…Official notice → - US
Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP,…
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
FDA · DeviceOrthofix U.S. LLCUS Nationwide distribution in the states of California, Colorado, and Missouri.Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *,…
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of The Netherlands,…Official notice → - US
- US
Baxter Healthcare Corporation recalls Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of AR, CA, FL, IA, IN, LA, MO, MT,…Official notice → - US
Baxter Healthcare Corporation recalls Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.