Manufacturer
51 recalls in our database name St. Jude Medical, Inc. as the manufacturing or recalling firm.
Of the 51 recalls from St. Jude Medical, Inc. we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (24%) are Severe.
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.
St Jude Medical is recalling 21 Ellipse DR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
St Jude Medical is recalling 15 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.
St Jude Medical is recalling 52 Ellipse VR cardioverter defibrillators worldwide due to damaged aluminum wires that may prevent high-voltage therapy delivery.
St Jude Medical is recalling 42 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.
St Jude Medical is recalling 27 Ellipse VR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
St Jude Medical is recalling 47 Ellipse VR ICDs worldwide due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
St. Jude Medical is recalling Deep Brain Stimulation leads where the most proximal unsegmented electrode may be made of MP35N instead of the required 90/10 platinum-iridium.
St. Jude Medical is recalling 986 Confirm Rx Insertable Cardiac Monitors because exposure to sub-freezing temperatures caused a transient battery voltage drop, resulting in an incorrect low battery indicator display.
St Jude Medical is recalling Merlin PCS Programmer Software to address an incorrect low battery indicator on Confirm Rx ICM devices caused by supply chain temperature exposure.
St Jude Medical is recalling Promote Quadra implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
St Jude Medical is recalling Fortify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access. Older devices may require permanent disabling of RF communication.
St Jude Medical is releasing new firmware for high voltage implantable cardiac devices to strengthen security against unauthorized access.
St Jude Medical is recalling Unify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
St Jude Medical is recalling 68,117 Quadra Assura MP implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
St Jude Medical is recalling 72,673 Quadra Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
St Jude Medical is recalling Unify Quadra implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
St Jude Medical is recalling implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
St Jude Medical is releasing new firmware for Merlin PCS programmers to strengthen security against unauthorized access to cardiac devices.
St Jude Medical is recalling Ellipse ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.
St Jude Medical is recalling Fortify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
St Jude Medical is recalling Unify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.
St. Jude Medical is recalling 17 Proclaim DRG Implantable Pulse Generators due to error messages during routine checks and transient overstimulation causing patient discomfort.
St. Jude Medical is recalling 1,744 Proclaim DRG Implantable Pulse Generators because the battery indicator status may be inaccurate.
St. Jude Medical is recalling 3,119 Infinity 5 and 7 Implantable Pulse Generators because battery longevity estimations may be inaccurate.
St Jude Medical is recalling 164,366 Assurity MRI pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.