Drugs & medicalClass II

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.

Read the official notice →
Date
2023-11-15
Country
United States
Brand
St. Jude Medical
Product
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure…
Classification
Class II
Units
Worldwide distribution - US Nationwide and the countries of ARGENTINA,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2025-04-02
  2. US
    Drugs & medicalClass II

    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…

    FDA · DeviceSt. Jude MedicalU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice →
  3. 2025-01-29
  4. US
    Drugs & medicalClass II

    St. 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    As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.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 →
  5. US
    Drugs & medicalClass II

    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 →
  6. 2024-07-24
  7. US
    Drugs & medicalClass II

    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.

    FDA · DeviceSt. Jude MedicalUS and CanadaOfficial notice →
  8. 2023-03-15
  9. US
    Drugs & medicalClass II

    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 →
  10. US
    Drugs & medicalClass II

    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 →
All 7 St. Jude Medical recalls →

Other drugs & medical recalls in the United States

  1. 2023-11-15
  2. US
    Drugs & medicalClass II

    Philips North America recalls Allura Xper IGTS Fixed Systems

    Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer…

    FDA · DevicePhilips North AmericaUnited States Territories of Puerto Rico, Guam, and Virgin IslandsOfficial notice →
  3. US
    Drugs & medicalClass II

    Securitas Healthcare LLC recalls Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm

    Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.

    FDA · DeviceSecuritas Healthcare LLCWorldwide distribution - US Nationwide and the country of Canada.Official notice →
  4. US
    Drugs & medicalClass II

    Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in…

    During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals.…

    FDA · DeviceMagellan Diagnostics, Inc.US Nationwide distribution.Official notice →
  5. US
    Drugs & medicalClass I

    Olympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190

    There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the…

    FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distributionOfficial notice →
  6. US
    Drugs & medicalClass I

    Medtronic Navigation, Inc. recalls StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is…

    Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.

    FDA · DeviceMedtronic Navigation, Inc.Worldwide Distribution: U.S. (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice →
  7. US
    Drugs & medicalClass I

    CareFusion 303, Inc. recalls Alaris PCA Module 8120

    Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

    FDA · DeviceCareFusion 303, Inc.Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, DC, DE,…Official notice →
See all drugs & medical recalls →