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 8 (16%) 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 28,817 Proclaim 5 and 7 Elite Implantable Pulse Generators because battery longevity estimations may be inaccurate.
St. Jude Medical is recalling Merlin@Home software to mitigate the risk of unauthorized access to pacemakers using radio frequency communications.
St Jude Medical is recalling 2,726 implantable pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
St. Jude Medical is recalling 10,453 Merlin PCS 3650 programmers worldwide to install new firmware that mitigates the risk of unauthorized access to pacemakers.
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 specific Anthem and Allure/Relieve pacemakers to mitigate the risk of unauthorized access via radio frequency communications.
St Jude Medical is recalling 2,741 Nuance pacemakers to install new firmware that mitigates the risk of unauthorized access to the devices' radio frequency communications.
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.
St Jude Medical is recalling 6,051 PM 1260 Assurity+ pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
St Jude Medical is recalling 4,828 ZENEX pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
St Jude Medical is recalling specific Unify and Quadra Assura cardiac resynchronization therapy defibrillators because they may exhibit premature battery depletion.
St Jude Medical is recalling approximately 90,563 Fortify and Fortify Assura implantable cardioverter defibrillators because they may exhibit premature battery depletion.
St. Jude Medical is recalling 9,529 Proclaim 7 Elite implantable pulse generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.
St. Jude Medical is recalling 54 Infinity 5 Implantable Pulse Generators due to a risk of therapy loss if exposed to monopolar electrosurgical devices.
St. Jude Medical is recalling 40 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices during medical procedures may cause a loss of neuromodulation therapy.
St. Jude Medical is recalling 443 Infinity 5 Implantable Pulse Generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.
St. Jude Medical is recalling 8,780 Proclaim 5 Elite implantable pulse generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.
St. Jude Medical is recalling 373 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices may cause a loss of neuromodulation therapy.
St Jude Medical is recalling specific implantable defibrillators because a lithium cluster in the battery can cause a short circuit and premature depletion.
St Jude Medical is recalling specific implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because a lithium cluster in the battery can cause a short circuit and premature battery depletion.
St Jude Medical is recalling implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators due to a battery defect that can cause premature depletion.
St. Jude Medical is recalling 127 Ellipse ICD devices because they may fail to deliver high-voltage therapy needed to treat life-threatening heart rhythms.
St. Jude Medical is recalling four units of the Percutaneous Trial Lead Kit Model 3086 because the included manual contained information for devices not approved in the US.
St. Jude Medical is recalling 2 units of Percutaneous Trial Lead Kit Model 3046 because the included manual contained information for devices not approved in the US.
St. Jude Medical is recalling 635 TorqVue FX Delivery Systems because the core wire could fracture during use.