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St. Jude Medical

St. Jude Medical Recalls

All product recalls associated with St. Jude Medical.

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Recall Summary

Total Recalls

19

Past Year

1

Class I (Serious)

0

Most Recent

Feb 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–19 of 19 recalls

CardioMEMS HF System (St. Jude Medical) – data migration (2025)

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.

FDAFeb 3, 2025Nationwide• St. Jude Medical

Merlin.net PCN Heart Failure Web App (St. Jude) – Data Migration Issue (2024)

Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.

FDANov 6, 2024CA, CT, GA +10 more• St. Jude Medical

CardioMEMS HF System (St. Jude Medical) – Cloud Data Migration Error (2024)

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.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

Oct 5, 2024

Nationwide

• St. Jude Medical

St. Jude Medical: 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.

FDAApr 30, 2024Nationwide• St. Jude Medical

St. Jude Medical, Atrial Fibrillation Division, Inc.: TactiFlex Ablation Sensor Enabled Ablation Catheter, Mode...

When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.

FDADec 18, 2023Nationwide• St. Jude Medical, Atrial Fibrillation Division, Inc.

St. Jude Medical: CardioMEMS Patient Electronic System (PES), Model Number ...

Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.

FDAOct 4, 2023Nationwide• St. Jude Medical

St. Jude Medical: CardioMEMS HF System Patient Electronics System (PES), Mo...

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 and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).

FDAFeb 7, 2023Nationwide• St. Jude Medical

St. Jude Medical: CardioMEMS HF System Hospital Electronics System (HES), M...

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 and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors when in close proximity to an active Hospital or Patient Electronics System (i.e., during readings).

FDAFeb 7, 2023Nationwide• St. Jude Medical

St. Jude Medical: CardioMEMS HF System PA Sensor and Delivery System, Model...

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 the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.

FDAFeb 7, 2023Nationwide• St. Jude Medical

St. Jude Medical, Cardiac Rhythm Management Division: Merlin.net model MN5000 Software

The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

FDAJun 17, 2022AL, AK, AZ +49 more• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Merlin 2 PCS MER37000 programmer Model MER3400 software

The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

FDAJun 17, 2022AL, AK, AZ +49 more• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Merlin PCS 3650 programmer Model 3330 software

There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.

FDAJun 17, 2022AL, AK, AZ +49 more• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Gallant DR Implantable Cardioverter Defibrillator REF # C...

Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Gallant HF Implantable Cardioverter Defibrillator REF# CD...

Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Merlin PCS 3650 programmer Model 3330 software

Laceration Risk

Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Gallant VR Implantable Cardioverter Defibrillator REF # C...

Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Merlin 2 PCS MER3700 programmer Model MER3400 software

Laceration Risk

Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardian Rhythm Management Division: ENDURITY Pulse Generator REF PM SN ***** St. Jude...

Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough

FDAMar 15, 2021Nationwide• St. Jude Medical, Cardian Rhythm Management Division

St. Jude Medical, Cardian Rhythm Management Division: ASSURITY Pulse Generator REF PM SN ***** ST. JUDE...

Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough

FDAMar 15, 2021Nationwide• St. Jude Medical, Cardian Rhythm Management Division