Manufacturer
14 recalls in our database name St. Jude Medical, Cardiac Rhythm Management Division as the manufacturing or recalling firm.
Of the 14 recalls from St. Jude Medical, Cardiac Rhythm Management Division we have scored against our rubric, 1 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (7%) 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 recalls Merlin 2 PCS model MER3700, software used to program and interrogate Abbott implantable medical devices.
St. Jude Medical recalled Merlin 2 PCS MER3400 programmer software version 1.1.2 revision 1 or earlier in an FDA Class II recall. The recall affects 622 units distributed across the United States and internationally.
St. Jude Medical's Merlin PCS 3650 programmer software may display overestimated predicted battery longevity for certain pacemakers. This could affect clinical decision-making regarding device maintenance and replacement timing.
St. Jude Medical's Merlin 2 programmer software can fail to stop a clinical Decrement Test and restore pacing parameters during in-clinic testing, affecting 401 devices worldwide.
St. Jude Medical's Gallant DR implantable cardioverter defibrillator has a Bluetooth malfunction preventing remote monitoring and reducing battery life. The device enters inductive-only telemetry mode, requiring in-clinic monitoring instead.
Certain Gallant VR Implantable Cardioverter Defibrillator units experience Bluetooth malfunction preventing remote monitoring and reducing battery longevity.
A software anomaly in the Merlin PCS 3650 programmer may cause an in-clinic pacing test to fail terminating and prevent restoration of the implanted device's normal settings. Approximately 30,069 affected devices have been distributed worldwide.
The Gallant HF Implantable Cardioverter Defibrillator (REF# CDHFA500Q) may experience a Bluetooth malfunction that prevents remote monitoring and reduces battery life. Consult your healthcare provider.
St Jude Medical is recalling 256 Ellipse ICDs because past updates may cause loss of wireless communication, preventing remote patient monitoring.
St. Jude Medical is recalling 2,906 Confirm Rx Insertable Cardiac Monitors because a software defect caused inappropriate low battery indicators.
St. Jude Medical is recalling Optisure Dual Coil Defibrillation Leads due to potential insulation cuts in the SVC shock coil.
St Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because some devices exhibit backup VVI operation due to a backup reset.
St. Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because a software reset may cause backup operation in implanted cardiac devices.
St Jude Medical is recalling Ellipse ICDs because internal capacitor damage may delay or prevent high voltage therapy delivery.