St Jude Medical Field Safety Notice

International Medical Devices Database

https://medicaldevices.icij.org/

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Try Synchromed or St. Jude . …

Cardiovascular Product Advisories | Abbott

https://www.cardiovascular.abbott/int/en/hcp/product-advisories.html

St. Jude Medical Field Sales Staff and Field Clinical Engineers will install this software upgrade in Merlin PCS and Model 3510 programmers in the field. Thereafter, upon initial …

Cardiovascular Product Advisories | Abbott

https://www.cardiovascular.abbott/us/en/hcp/product-advisories.html

A field safety notice (FSN) was issued on Jan. 29, 2020, to physicians and hospitals who received coronary-specific lots of two catheters used in coronary angioplasty …

Abbott (formally known as “St. Jude Medical”) Recalls …

https://www.fda.gov/medical-devices/medical-device-recalls/abbott-formally-known-st-jude-medical-recalls-assuritytm-and-enduritytm-pacemakers-potential

Ellipse™ VR/DR implantable cardioverter defibrillators …

https://www.gov.uk/drug-device-alerts/medical-device-alert-ellipse-vr-dr-implantable-cardioverter-defibrillators-potential-failure-mode

St Jude Medical issued a Field Safety Notice (FSN) (340Kb), describing a potential failure mode which can delay or reduce the therapy that can be delivered by the …

Field safety notices - 16 to 20 November 2015 - GOV.UK

https://www.gov.uk/drug-device-alerts/field-safety-notices-16-to-20-november-2015

Field safety notices - 16 to 20 November 2015 - GOV.UK Home Alerts, recalls and safety information: drugs and medical devices Field safety notices - 16 to …

Medical Device Alert (FINAL) - GOV.UK

https://assets.publishing.service.gov.uk/media/5485ac0240f0b60244000283/con149820.pdf

Manufactured by St Jude Medical. Problem Action Risk of worsening heart failure symptoms due to wear and/or abrasion of lead insulation after implantation. Action by All …

SUMMARY OF SAFETY AND EFFECTIVENESS …

https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140033B.pdf

PMA P140033: FDA Summary of Safety and Effectiveness Data Page 2 of 54 MR Conditional pacemakers are conditionally safe for use in the MRI environment when used …

Abbott (St Jude Medical Inc.) - 519686 - 04/12/2017 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abbott-st-jude-medical-inc-519686-04122017

Your response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak …

Medical Device Alerts - MDA's - 2003 - 2012

https://www.health-ni.gov.uk/articles/medical-device-alerts-mdas-2003-2012

Medical Device Alert: Implantable cardioverter defibrillator (ICD) leads Manufactured by St Jude Medical. This Medical Device Alert has been issued as there …