Manufacturer

St. Jude Medical

22 recalls in our database name St. Jude Medical as the manufacturing or recalling firm.

What the numbers show

Total: 22
Critical: 0
Severe: 2
Most recent: 2025-04-02

Of the 22 recalls from St. Jude Medical we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–22 of 22

HighFDA (Devices)·Z-1427-2025·2025-04-02
CardioMEMS Heart Failure Monitoring System Recalled for Data Migration Issues
St. Jude Medical is recalling the CardioMEMS Heart Failure System due to data migration issues resulting in duplicated or missing patient information.
Product
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary art
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2025·2025-01-29
Heart Failure Monitoring System Unable to Transmit Patient Readings After Cloud Migration
The Merlin.net Heart Failure monitoring application cannot transmit patient readings after a data migration to a cloud environment. Some systems (25 total) distributed across 13 U.S. states are affected.
Product
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (H
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0989-2025·2025-01-29
CardioMEMS Heart Failure Monitoring System Cloud Migration Causes Inaccurate Pressure Readings
St. Jude Medical recalled 431 CardioMEMS HF pressure measurement systems after a cloud data migration reverted systems to outdated configuration, causing inaccurate pulmonary artery pressure readings.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2025·2025-01-29
CardioMEMS HF Pressure Measurement System Recalled for Inaccurate Readings
St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System due to a cloud data migration that caused the system to revert to an outdated configuration, resulting in inaccurate pulmonary artery pressure readings.
Product
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2348-2024·2024-07-24
Agilis NxT Steerable Introducer Recalled for Dilators Too Short
St. Jude Medical is recalling 129 units of the Agilis NxT Steerable Introducer due to dilators that are too short and will not extend outside the introducer sheath. The defect may prevent proper device function.
Product
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0218-2024·2023-11-15
CardioMEMS Patient Electronic System power connector damage risk
St. Jude Medical is recalling CardioMEMS Patient Electronic System (Model CM1100) because the power connector plug may become damaged and frayed if bent beyond 90 degrees. This could cause device malfunction or electrical hazard.
Product
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1220-2023·2023-03-15
CardioMEMS Patient Electronics System Recalled for Excessive Radiofrequency Emissions
CardioMEMS heart-failure monitoring devices are recalled due to radiofrequency emissions that can interfere with other medical devices like pacemakers when operating nearby.
Product
CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1225-2023·2023-03-15
CardioMEMS Heart Failure Sensor May Give Inaccurate Readings at High Elevations
St. Jude Medical is recalling 317 CardioMEMS PA Sensors due to operation outside their intended frequency range at elevations above 2,000 feet, which may cause inaccurate pressure readings or signal acquisition problems.
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1223-2023·2023-03-15
CardioMEMS PA Sensor Operates Outside Frequency Range at High Elevations
Select CardioMEMS CM2000 PA sensors may operate outside their intended frequency range above 2,000 feet elevation, potentially causing inaccurate readings or signal acquisition problems in heart failure monitoring.
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1224-2023·2023-03-15
CardioMEMS PA Sensor models affected by radio-frequency range at high elevations
St. Jude Medical recalls CardioMEMS PA Sensors that may operate outside intended frequency range above 2,000 feet elevation, risking inaccurate readings in heart failure monitoring. Approximately 1,905 units affected.
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1221-2023·2023-03-15
CardioMEMS Hospital Electronics System RF Emissions May Interfere With Implanted Devices
St. Jude Medical is recalling the CardioMEMS HF System (Model CM3000) due to excessive radiofrequency emissions that may interfere with pacemakers, defibrillators, and other implanted devices during use. The recall affects 1,905 units distributed worldwide.
Product
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physician
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1219-2023·2023-03-15
CardioMEMS Heart Monitoring System Emissions May Interfere With Pacemakers
FDA recalls CardioMEMS HF System patient monitor for radiofrequency signal emissions that can interfere with pacemakers, defibrillators, and other implanted medical devices. The emissions exceed radiofrequency limits.
Product
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1218-2023·2023-03-15
CardioMEMS Heart Failure Monitor Recalled for Radiofrequency Emissions
St. Jude Medical is recalling certain CardioMEMS heart failure monitoring devices due to excessive radiofrequency emissions that could interfere with pacemakers, defibrillators, and other implanted medical devices when in close proximity.
Product
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1284-2015·2015-03-25
St Jude Medical Recalls TactiSys Quartz Pack for Configuration Update
St Jude Medical is recalling 89 TactiSys Quartz Packs because a configuration update is needed to ensure the device appropriately recognizes all TactiCath catheters.
Product
TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0177-2015·2014-11-12
St. Jude Medical Recalls Electrophysiology Catheters Due to Incorrect Packaging
St. Jude Medical is voluntarily recalling 26 electrophysiology catheters because the packaging contains the wrong device model. No serious injuries have been reported.
Product
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0108-2015·2014-10-29
St. Jude Medical Recalls Fast-Cath Trio Hemostasis Introducer Due to Dilator Defect
St. Jude Medical is voluntarily recalling 220 units of the Fast-Cath Trio Hemostasis Introducer because the dilator is too small to allow guidewire advancement, potentially causing procedural delays.
Product
St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labelin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0187-2014·2013-11-20
St. Jude Medical Recalls Safire Duo Ablation Catheters Due to Connector Error
St. Jude Medical is voluntarily recalling 46 Safire Duo Ablation Catheters because they have a cable connector configuration that differs from the intended design.
Product
Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0174-2014·2013-11-13
St. Jude Medical Recalls Ablation Catheters Due to Incorrect Instructions
St. Jude Medical is recalling 59 ablation catheters shipped with the wrong Instructions for Use (IFU). The recall covers specific batches distributed in six US states.
Product
US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maxim
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1836-2013·2013-08-07
St. Jude Medical Recalls Eon Mini Implantable Pulse Generators
St. Jude Medical is recalling 34,617 Eon Mini implantable pulse generators worldwide due to a battery weld issue that can cause loss of pain relief.
Product
Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1785-2013·2013-07-31
St. Jude Medical Recalls Eon and Eon Mini Charging Systems
St. Jude Medical is recalling Eon and Eon Mini charging systems due to reported warmth or heating at the implant site during charging.
Product
Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. Product Usage: The Eon Wall Charger (3701) provides the capability to recharge the IPG Batte
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1739-2013·2013-07-24
St. Jude Medical Recalls Eon Mini Spinal Cord Stimulator Chargers
St. Jude Medical is recalling Eon Mini chargers due to reports of skin burns and discomfort at the implant site during charging.
Product
Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1738-2013·2013-07-24
St. Jude Medical Recalls Eon Spinal Cord Stimulator Charging Systems
St. Jude Medical is recalling Eon and Eon Mini charging systems due to reports of skin burns and discomfort at the implant site during use.
Product
Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syn
Category
Medical Device
Distribution
Distributed nationwide